Director of Regulatory Affairs
The Director of Regulatory Affairs is responsible for defining and implementing regulatory strategies to obtain global approvals of new/modified devices and combination products to support meeting Anika’s business objectives. This role requires the ability to analyze complex technical and medical information and formulate strong regulatory arguments that can be defended with regulatory agencies such as the FDA and international Health Authorities. The Director of Regulatory Affairs must also ensure compliance with global regulations for design controls, cGMP, facility registration, device listing, licenses, safety reporting, complaints, clinical trial requirements, post-market surveillance, labeling, and permissible marketing communication. This position reports to the VP of Regulatory/ Clinical Affairs. The Director of Regulatory Affairs manages a staff of Regulatory Affairs professionals in the U.S and Europe. The Director of Regulatory Affairs provides the Regulatory Affairs department interface to executive management and is one of the top leaders in Anika.
Strategic Focus Areas:
- Guiding the Anika organization around new and changing regulations in US, Europe and other international territories.
- Develop a regulatory affairs team to support both operational and strategic areas of the business
- Work with regulators to achieve predictability in product approval strategies
- Working closely with Marketing, R&D, Manufacturing, and Clinical Affairs, develop the regulatory strategy to gain market approval for new or modified devices/combination products consistent with corporate objectives.
- Lead the preparation of complex submissions including PMAs, NDAs, BLAs, 510(k)s, IDEs, Notified Body/Competent Authority application, Health Canada licenses, and submissions to other international Health Authorities.
- Interact proactively and persuasively with global regulatory agencies in order to gain approvals.
- Guide product development teams in developing new products in accordance with Design Control regulations.
- Ensure clinical studies are designed and executed in full compliance to GCP, ICH, and pertinent global regulations.
- Provide oversight of regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submitted.
- Ensure product labeling and promotional materials are compliant with regulations.
- Ensure all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance.
- Possesses in-depth understanding of US and OUS regulation requirements. Actively reviews new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates pertinent information.
- Responsible for global safety reporting and complaint handling in accordance with regulations.
- Hire, manage, and develop staff of regulatory professionals in the U.S.
- Contract and manage specialized regulatory consultants as necessary.
- Accountable for developing and meeting regulatory timelines and budgets.
- Represent Anika during audits by regulatory agencies.
Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current regulatory trends.
Manages regulatory staff and consultants
Experience, Knowledge, and Skills Required:
- BA/BS in the life sciences, or engineering with MS preferred
- Requires a 10+ years of regulatory experience in the medical device/pharmaceutical/biologics industry.
- Requires experience developing and successfully defending complex regulatory submissions for medical devices (PMA, 510(k), IDE) and combination devices. Experience with pharmaceutical regulatory submissions (IND, NDA) is desirable.
- Requires experience directly, and successfully, interfacing with the FDA and other regulatory bodies.
- Experience with international device and drug regulatory submissions required, including EU, Health Canada, FDA, and other ROW health authorities.
- 5+ years of managerial experience required including direct supervisory experience and experience building and meeting budgets and timelines.
- Requires strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments.
- Strong project management and problem-solving skills
- Regulatory Affairs Certification preferred