Reports to: Vice President, QA and Regulatory Affairs
The Director, Regulatory Affairs plans, organizes, coordinates and prepares regulatory submissions globally, including, but not limited, to IDEs, PMAs, 510(k)s, technical files, design dossiers, clinical trial Competent Authority notifications and submissions. S/he is responsible for obtaining clinical and marketing approvals for new products and expanded indications. S/he will be a key collaborator on regulatory strategy, with an ability to establish and execute departmental objectives. The Director, Regulatory Affairs leadings efforts in building and refining regulatory processes and procedures, and provides quality and timely regulatory expertise and support to assure compliance for company processes, including product/clinical development, marketing functions, labeling and promotional materials. S/he maintains establishment registrations and device listings and other related regulatory requirements such as clinical trials.gov. Additionally, s/he works proactively with project teams to ensure the accuracy and timeliness of regulatory documentation and responses to regulators to ensure prompt regulatory review and approval. Overseeing the function, s/he is responsible for managing the group’s budgets, building and managing a team over time and mentoring other employees.
- Manage directed regulatory projects, develop and execute regulatory plans.
- Working proactively with project teams, manage submissions and all regulatory matters.
- Lead efforts in the development and documentation of regulatory submissions, processes and procedures and monitoring plans.
- Write, format, review, and edit regulatory submissions and submit documentation in accordance with regulatory requirements and guidance documents.
- Maintain matrix of device approvals by product and country.
- Manage and maintain ongoing submissions such as IDE annual reports/notices, establishment registrations and device listing.
- Manage the tracking and archiving of regulatory submissions and documentation, including, but not limited to, regulatory agency correspondence, labeling, and data packages.
- Interact proactively with regulatory authorities. Establish and maintain effective and trustworthy working relationships to help meet company goals.
- Approve product labeling, technical publications, and promotional materials, assuring regulatory requirements are met and all product claims are adequately supported.
- Participate in medical device/vigilance reporting determinations and provide documented justifications.
- Provide guidance on product/process quality and risk assessments.
- Review and approve product design and specification changes; assess and document the impact of changes on the current regulatory approvals.
- Successfully manage the growth of the Regulatory Affairs time over time, meeting budgetary requirements, managing assigned team members and mentoring staff members as appropriate.
- Bring a “can do” spirit to work and deliver on assigned responsibilities.
Education or Certification Requirements
- BS in Life Sciences or related disciplines required; higher education preferred.
- RAPs Certification preferred.
Professional Work Experience
- 10+ years of direct and hands-on experience in Regulatory Affairs.
- Experience in biotech, pharmaceutical and/or medical device industries preferred.
- Experience in a start-up or small company preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Sound basis of regulatory knowledge of US medical device regulations (21 CRF Parts 801, 812, 803, 806, 807, 810, 812, 814, 822, 830, 860), Medical Device Directive/Regulation, and other International regulations, e.g. JPAL, KFDA, GCC, MDSAP.
- Experience and proven ability in preparing submissions, e.g. IDEs, 510(s), PMA(s), technical files, OUS dossiers.
- Knowledge of Quality Systems requirements such as QSR, ISO 13485, and CAMDCAS. GLP and GCP.
- Direct experience working with regulatory agencies on a global basis.
- Strong project management skills and ability to manage complex projects and timelines within a team environment.
- Ability to identify compliance risks and escalate when necessary.
- Close involvement in at least one complete medical device product development cycle from product development through commercialization.
- Demonstrated ability to stay abreast of changing FDA and international regulations and standards.
- Excellent technical aptitude and document formatting and publishing skills.
- Strong problem solving skills and ability to deal with changing priorities.
Other Essentials and Key Success Factors:
- Successful track record of working in high-growth and dynamic organizations.
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well.
- Evidence of "hands-on" experience and expertise.
- Proven and successful track record as a team-player and collaborator in small working environments.
- Highly organized and detail oriented with a passion to deliver quality results.
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation.
- Highest levels of professionalism, confidence, personal values and ethical standards.
- Some domestic and international travel may be required.
The description and requirements outlined above are general; additional requirements may apply.