Regulatory Affairs Project Manager Resume Sample
Elisha O'Conner
7634 Clyde Crossroad,
New York,
NY
+1 (555) 569 9361
Work Experience
Regulatory Affairs Project Manager
06/2016
-
PRESENT
Boston, MA
- Provides leadership by communicating and providing guidance towards achieving department objectives
- Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Acts as a mentor to less-experienced staff
- Act as independent regulatory representative in International projects
- Support all regulatory activities related to the site at Wiesbaden-Delkenheim
- Provides global strategic input (including all feasible alternatives and associated risks)
- Drives cross functional alignment with issues that could have Regulatory ramifications
- Working knowledge of US and EU regulatory requirements for biological and medical device products
Biocides Regulatory Affairs Project Manager
06/2010
-
01/2016
San Francisco, CA
- Proven experience of preparing and authoring regulatory submissions for biological products
- Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, and Visio) with demonstrated skills in the use of information management systems
- Profound working knowledge of cGxP regulations and regulatory trends as they pertain to the stated responsibilities
- Allocates/co-ordinates work within the team/project and/or contributes to technical/professional direction for a discipline
- Lead the coordination and management of cross-functional team comprising of quality, regulatory, manufacturing, and engineering to develop, communicate, and measure progress against goals and metrics for program success
- Lead efforts to determine and develop strategic approaches for entire program
- Track and manage project deliverables and cost against budget; report and advise on recovery plans necessary to achieve budget targets
- Develop tracking spreadsheets, assemble presentations, dashboards and other project tools as necessary to drive the overall program
Education
Grand View University
2006 - 2010
Bachelor's Degree in Life Sciences
Professional Skills
- Strong proven personal development, motivational skills and high level of initiative
- ) Strong regulatory submission experience with PMA's; 2.) Design Control Experience; 3.) CBER experience
- Strong teaching and coaching skills to teach and coach a younger team of Regulatory colleagues
- Solid problem-solving and decision-making skills; ability to summarize complex information effectively
- Demonstrated ability to juggle and prioritize multiple competing priorities and complete tasks on-time
- Demonstrated skills managing multiple project timelines
- Excellent analytical skills and the ability to apply policies and general regulations to specific products or projects
How to write Regulatory Affairs Project Manager Resume
Regulatory Affairs Project Manager role is responsible for german, english, french, manufacturing, training, database, procurement, reporting, design, education.
To write great resume for regulatory affairs project manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Affairs Project Manager Resume
The section contact information is important in your regulatory affairs project manager resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Affairs Project Manager Resume
The section work experience is an essential part of your regulatory affairs project manager resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory affairs project manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory affairs project manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Affairs Project Manager resume experience can include:
- Excellent documentation skills and the ability to coordinate multiple projects and priorities to meet required due dates is required
- Excellent communicator (written/verbal) with the ability to listen, organise and prioritise
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies
- Communicate effectively in English (both written and verbal)
- Excellent team player with a strong customer-orientation
- Strong background in Risk Management (EN ISO 14971), Usability Engineering (EN 62366), Biological Safety (ISO 10993-x)
Education on a Regulatory Affairs Project Manager Resume
Make sure to make education a priority on your regulatory affairs project manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory affairs project manager experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Affairs Project Manager Resume
When listing skills on your regulatory affairs project manager resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory affairs project manager skills:
- Strong MS Word and Adobe Professional document management skills including: formatting, creation/verification of bookmarks, hypertext links, tables of contents
- Experience working effectively across cultures and in complex matrixed environment
- Good skills in MS PackOffice and an ERP (preferably AX Dynamics)
- Relevant experience with working in a software or hardware development environment and a good understanding of design control requirements
- Proven experience preparing and authoring regulatory submissions for biological products
- Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications
List of Typical Experience For a Regulatory Affairs Project Manager Resume
1
Experience For Biocides Regulatory Affairs Project Manager Resume
- Knowledge of QMS requirements for manufacturing related activities (e.g. Good Manufacturing Practices, US FDA 21 CFR 820, Risk Management)
- Lead specific business unit and/or sector wide initiatives that directly impact the effective state of regulatory compliance
- Developing and maintaining regulatory affairs department procedures and process improvements
- Supports manufacturing and procurement in the management of change to existing commercial products by managing, compiling and writing post-approval submissions
- Contributes to writing and editing technical documents
- Provides leadership and guidance (including training) to other members of the Regulatory / Quality staff
2
Experience For Regulatory Affairs Project Manager Resume
- Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments
- Assesses changes in existing products to and determines the need for new / revised licenses or registrations
- Coordinate cross-functional activities regarding technical documentation (i.e. with R&D, Clinical Affairs)
- Reviews device labeling or compliance with submissions and applicable EU regulations
- Participate in group and sub-team meetings and provide status updates and input to development projects, representing RA as a sub-team member
- Assist with acquisitions/divestitures, including due diligence and post-acquisition assessment and education as requested
3
Experience For Biocides Regulatory Affairs Project Manager Resume
- Maintains product labeling in compliance with laws and regulations
- Develops and approves labeling specifications in compliance with SOPs
- Prepare and provide status update, communications, and other presentations across the business unit at all levels
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
- Provides guidance and expertise
- Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail
- Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems
4
Experience For Regulatory Affairs Project Manager Resume
- Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations - Interfaces directly with FDA and other regulatory agencies
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release
- Conducts reviews of product and manufacturing changes for compliance with applicable regulations - Reviews protocols and reports to support regulatory submissions
- 4) Have understanding of the medical device regulatory landscape
- Understand client’s desired outcomes and work collaboratively to ensure deliverables meet quality standards
5
Experience For Biocides Regulatory Affairs Project Manager Resume
- Develop new regulatory policies, processes and SOPs and train key personnel on them
- Evaluate regulatory risks of division policies, processes, procedures
- Recruit, develop and mentor regulatory professionals
- At least four (4) years of experience with Perrigo or another company in the Pharmaceutical, medical device or other medical products/health care industry with progressive experience managing projects of complexity, is required
- Oversee processes involved with maintaining annual licenses, registrations, listings and patent information
- Assist in the development of multi- country regulatory strategy and update strategy based upon regulatory changes
- Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events Actively contribute to the development and functioning of the crisis/issue management program
- Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies Report adverse events to regulatory agencies and internal stakeholders
6
Experience For Regulatory Affairs Project Manager Resume
- Individuals execute and manage technical and scientific regulatory activities
- Completed work is reviewed from a relatively long- term perspective for desired results
- Individual is recognized as a discipline expert and resource in regulatory affairs
- Mentor RA associates to ensure regulatory requirements are identified and addressed in product development teams
- Keep abreast of regulatory requirements in the US and countries where ADC intends to offer product for sale
- Work with the Regulatory leadership to prepare regulatory plan/strategy for product introductions
- Manage the preparation of registration documents as required for international markets
7
Experience For Biocides Regulatory Affairs Project Manager Resume
- Ensure that submissions are complete, properly formatted, and comply with applicable regulatory requirements
- Make certain that appropriate documentation is maintained to record regulatory decisions made in design and development activities
- Review and make recommendations on policies and procedures that impact regulatory activities
- Recruit, develop and manage regulatory professions
- Provides Regulatory Affairs support to site and customers. Prepares, submits and maintains DMFs, BLA and 510K submissions
- Evaluates current processes and systems with regard to industry best practices, available resources, and evolving regulations and guidelines and propose changes targeting greater efficiency and continued compliance
- Co-ordinates and supports Lonza regulatory information for the Walkersville site
- Anticipates, evaluates and implements trends and innovations in the Regulatory Affairs arena
8
Experience For Regulatory Affairs Project Manager Resume
- Contributes to the development and implementation of procedures and processes
- Develops and maintains high level contacts with external RA stakeholders including customers, regulatory authorities, academic institutions, scientific experts as necessary
- Develops and maintains relationships among the Lonza worldwide Regulatory Affairs function
- The incumbent normally receives little instruction on day-to-day work and receives general instructions on new assignments
- Manage local or global projects as regulatory site representative
- Establish and maintain relationship to OEM manufacturers and assure compliance to international regulations
- Build interface to Notified Body, provide submissions, assist in audits
- Assist in creation and maintenance of Technical Documentation
- Support site related batch verification activities
9
Experience For Biocides Regulatory Affairs Project Manager Resume
- Train junior colleagues on regulatory activities
- Provide consultation on local laws
- Manages FDA, EU and other regulatory submission process; oversees the authorship and publication of electronic submissions
- Interprets and applies government (e.g. FDA) regulations to business practices and provides regulatory input, advice, and guidance to the organization
- Understands the overall business environment, the orthopedic industry and the marketplace
- Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to software medical devices, biologic, drugs and combination products
- Understands design control requirements and can apply that knowledge into practice
- Manages one or more small-scale regulatory programs with well-defined plans and delivery methodologies including continuous improvement activies and compliance related projects
- Provides input to establishing program objectives, timelines, milestones and budgets to achieve departmental and organizational objectives
10
Experience For Regulatory Affairs Project Manager Resume
- Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other functions on program objectives and execution plans on initiatives such as business development, major change projects, new product development, etc
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions
- Direct involvement in daily tasks, metrics development and implementation where necessary for successful progam execution
- Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets
- Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions
List of Typical Skills For a Regulatory Affairs Project Manager Resume
1
Skills For Biocides Regulatory Affairs Project Manager Resume
- Demonstrated ability to work successfully in complex business and project areas, leveraging interpersonal skills and technical skills to optimize results
- Working experience in a medical technology company
- Working experience in a multi-cultural, international environment
- Experience interpreting and applying U.S. FDA regulations
- Experience delivering presentations and influencing stakeholders at all levels in an organization
- Experience in creation of FDA regulatory submissions using publishing software tools (Liquent InSight, Lorenz Docubridge or similar)
- Relevant experience with working and supporting Medical Devices Clinical Trials
- Demonstrated ability to be assertive and willing to make decisions
2
Skills For Regulatory Affairs Project Manager Resume
- Experience coaching people is required
- Excellent working knowledge of medical device regulations such as FDA 510(k), European Medical Device Directive and Health Canada
- Experience driving initiative and change management across a Business Unit
- 2) Facilitates meetings...keeps things organized, takes good minutes, action items, etc
- Operates under Quality and Regulatory Directives
- Experience in technical file management in an international MedTech environment
- Solid knowledge of the European Medical Device Directive and European Medical Device Regulations
- Relevant experience with international regulations and submissions within regulatory function in medical devices industry
- Follow-up the brands with strong supported claims, review and approve local advertising material
3
Skills For Biocides Regulatory Affairs Project Manager Resume
- Safety and/or Quality experience is highly desireable
- Monitoring the global regulatory developments and deploy these new or updated requirements via the Quality Management System and/or training and coaching
- Reviewing marketing and communications material and assess compliance against relevant regulations and product requirements
- Working knowledge of US and EU regulatory requirements for biological and pharmaceutical products
- Participating in Product Development and Clinical Innovation teams, by providing regulatory strategy, timelines, and deliverables
- Reviewing Engineering Change Requests and assess regulatory impact of product changes on regulatory strategy and submissions
- Assisting in RA activities related to our fixed/mobile systems, software applications, and innovation devices
- Fulfils Regulatory activities in support of the site and customer goals including submission scheduling across the network
4
Skills For Regulatory Affairs Project Manager Resume
- Provide expert advice on regulatory requirements for advertising and promotion labeling of ADC products
- Fulfills Regulatory activities in support of the site and customer goals including submission scheduling across the network
- Provides strategic input on Virtual Manufacturing / OBL activities (including all feasible alternatives and associated risks)
- Adept in creating cross-functional partnerships
- Expertise in support of Commercial communications strategy and implementation of Advertising and Promotional materials for the US market
- 3) Ability to handle large complex activities with big moving pieces (cross-functionality)
- Drive remote manufacturing site personnel to ensure timely execution of tasks and overall timely completion of project work streams
- Gather progress updates and conduct regular reporting to leadership stakeholders
5
Skills For Biocides Regulatory Affairs Project Manager Resume
- Sensitivity to WE culture and ways of doing business is helpful
- Work in a fast-paced, high pressure and changing environment in an autonomous manner
- Knowledge and understanding of scientific, regulatory and trade dress terminology
- Working in healthcare, pharmaceutical, Medicare or related field
- Able to work in a team environment and exert influence without alienating others
- In depth knowledge in the filed of Regulations and Standards affecting the Medical Device Industry
- Bachelors of Science focused in Engineering or Science discipline
- Monitor New and Changing Requirements (NCR), and troubleshoot significant issues with regulatory processes and product issues
6
Skills For Regulatory Affairs Project Manager Resume
- Guide the use of industry standards in regulatory submission and supporting documentation within assigned Business Unit(s)
- Support the development and implementation of regulatory education and training of industry standards across the business sector
- Provides technical expertise and consulting to technical and business strategies
- Provide regulatory input to cardiovascular devices (Class III active implantables) product lifecycle planning
- Provide strategic input and technical guidance on regulatory requirements to new product development and sustaining teams
- Perform technical documentation and risk management assessments during a change control
- Support in providing technical answers to Health Authorities where needed
7
Skills For Biocides Regulatory Affairs Project Manager Resume
- Creates or reviews as applicable plans/protocols and reports, including Risk Management documentation, to support regulatory submissions
- Drives cross functional alignment with issues that could have Regulatory / Quality implications on Virtual Manufacturing / OBL activities
- Conducts reviews of product and manufacturing changes for compliance with applicable regulations (Change Control)
- Complies with EU and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
- Creates, reviews and approves engineering change orders
- 5) Understanding of what it takes in order to get approval in the European market (for medical devices)
- Adept in collaboration in a team environment
- International treaties and regional, national, local and territorial trade requirements, agreements and
- 1) Well-versed with Microsoft Project (and Excel workbooks)
8
Skills For Regulatory Affairs Project Manager Resume
- Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, IDE’s, PMA’s, Technical Files, and Design Dossiers
- Develop, implement and maintain regulatory SOP’s
- Ensures regulatory compliance for products
- Provides RA support to site and customers. Prepares, submits and maintains necessary dossiers and import/export licenses for the site
- Evaluation of current processes and systems with regard to industry best practices, available resources, and evolving regulations and guidelines and propose changes targeting greater efficiency and continued compliance
- Demonstrated ability to set and make clear priorities
- Proven track record of relevant working experience as regulatory or quality or research and development expert in a regulated environment
9
Skills For Biocides Regulatory Affairs Project Manager Resume
- Proven track record of successful project management or change experience
- Work effectively on project teams
- In Ad/Promo regulatory experience
- Experience in a regulated industry (e.g., medical products, nutritionals)
- Experience with EU Medical Device Directive (MDD) 93/42/EEC and exposure to EU Medical Device Regulation (MDR) 2017/245 and industry standards
- 510K submission experience
10
Skills For Regulatory Affairs Project Manager Resume
- 510K global submission experience
- Demonstrated ability to make sound business judgments
- Five (5) to seven (7) years experience in the medical industry with at least five (5) years in Regulatory Affairs of Medical Devices
- Co-ordinates and supports Lonza regulatory information for the Verviers site
- Anticipation, evaluation and implementation of trends and innovations in the RA arena
- Contributes to the development, implementation of procedures and processes
- Develops and maintains relationships among the Lonza worldwide RA function
List of Typical Responsibilities For a Regulatory Affairs Project Manager Resume
1
Responsibilities For Biocides Regulatory Affairs Project Manager Resume
- Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions and submits pre-market submissions to regulatory authorities, as per business timelines
- Ad/promo experience
- Manage update and maintenance of legacy technical documentation; propose and implement actions following GAP analysis with respect to MDD and MDR
- Prepares and files regulatory renewal / extension applications to ensure continued market access, per business direction
- Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
- Understands and applies regulatory requirements and their impacts for submissions
2
Responsibilities For Regulatory Affairs Project Manager Resume
- Ensures compliance with pre- and post-market product approval requirements
- Supports regulatory inspections as required
- Supports and encourages a collaborative, open and team based culture across his / her organization and the larger Regulatory Affairs organization
- Serve as an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements
- Interacts with and represents GEHC in activities with regulatory agencies and others as needed
- Manage project team to update all technical files in the framework of MDR implementation
- Prepare and manage product risk management meetings
- Ensure implementation of all required actions to update technical documentation
- Ensure clinical risks identified in process risk analysis are duly reported into the product risk analysis
3
Responsibilities For Biocides Regulatory Affairs Project Manager Resume
- Ensure consistency between all risk management files
- Merge all the technical documentation of the SBU, in the context of the company re-organization
- Ensure compliance with applicable and accurate standards and our SOPs
- Provide support to Clinical Affairs and R&D in the creation of biocompatibility and usability studies
- Manage sub-projects, together with R&D and QA, to improve the technical file management process (i.e. change control, process risk management, device master record)
- Ensure the information contained in department databases is up-to-date
4
Responsibilities For Regulatory Affairs Project Manager Resume
- Flexibility, perseverance, rigor and a methodical nature
- Prepares robust regulatory applications and design dossiers per applicable EU regulations
- Maintains CE-Mark certifications per Annex II sections 3 & 4 of Medical Device Directive 93/42/EC, including renewal applications and change reporting to Notified Bodies
- Creates, reviews and approves change requests
- Independently interacts and builds partnerships with regulatory agencies
- Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements
- Profound regulatory affairs related expertise
5
Responsibilities For Biocides Regulatory Affairs Project Manager Resume
- In depth knowledge of ISO 13485, and the EU Medical Devices Directives (MDD and AIMDD). It also desirable to have knowledge of the new EU Medical Device Regulation
- Responsible for working with global and cluster head to develop the strategy as well as preparing the regulatory submissions in compliance with global /local requirements and ensure that submissions are well planned and meet current standards and that submission schedules are adhered to
- Lead to the resolution of issues raised either internally or by Health Authorities to ensure a rapid and efficient resolution
- Initiate and/or contribute to process improvements, and inspection readiness
- Plan, schedule and arrange the majority of own activities
- Train the organization on pharma requirements as per global and local SOPs
- Proactive verbal and written communication style at all levels
- Work independently with a designed delegation scheme
6
Responsibilities For Regulatory Affairs Project Manager Resume
- Understands business needs and impact of regulatory issues on these
- Percent of Travel: 25% at least
- Tenacious and delivery focused
- Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
- Able to handle multiple tasks/projects and manage priorities accordingly
7
Responsibilities For Biocides Regulatory Affairs Project Manager Resume
- Experience in RA Projects is required
- Good working relationship with regulatory bodies
- International clinical and regulatory experience desired
- Making the technical file available for submissions in the rest of the world, and support our colleagues in obtaining the local approvals
- Represent the regulatory organization on the design, development and implementation of any PLM system
- Lead the process to interpret new and existing regulatory requirements as they relate to sector products and lead team development of business plans for sector management review that assures compliance to these regulations
- Act as the lead regulatory representative on Quality System improvement initiatives and assist with the development and implementation of department policies and procedures
- Primary RA interface with Commercial Area and in collaboration with the RA personnel in the affiliates
8
Responsibilities For Regulatory Affairs Project Manager Resume
- Experience in the area of worldwide regulatory affairs (both submissions and compliance) at medical device companies, preferably under the Class II and III medical device R & D and manufacturing environment
- Skilled in lifecycle management and eCTD requirements
- Fluent in local language required
- Knowledge of applicable Medical Device Standards (IEC 62304, IEC 62366, ISO 14971, ISO 14155, others)
- Deploy the international regulation into daily practice
- PMP certification is a nice to have, but not a requirement
9
Responsibilities For Biocides Regulatory Affairs Project Manager Resume
- Contract assignment, duration 12 months
- Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations
- Defining clinical and regulatory strategies and timelines for product submissions of mainly standalone medical products and related software in the field of interventional X-Ray
- Assuring the compliancy and quality of the technical file by guiding the responsible disciplines; Compile the submission files and obtain approvals in the USA (510(k)), Canada and Europe (MDD)
- 2+years Ad/Promo experience
- Coach and Educate more junior Regulatory Co-workers (In Pune, Bangalore, Best)
- Drive multiple project work streams in parallel; ensure on-time completion of individual tasks and overall timely completion of project work streams
10
Responsibilities For Regulatory Affairs Project Manager Resume
- Drive cross-functional business partners to a strategy and track progress
- Collaborate with in-function regulatory team members for document updates
- Support development of business processes and procedures for execution of project work streams
- Promote creative solutions as needed
- Maintain current regulatory databases and produce various reports as needed
- Provide basic regulatory guidance to cross-functional teams
- Review design control documents which include those associated with design inputs and design outputs
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