Principal Regulatory Affairs Specialist

Job description

Job responsibilities

• Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activities
• Providing training, coaching and mentoring to other regulatory affairs specialists
• Assisting in strategic decision making, and representing regulatory at all levels of the business
• Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure…
• Prepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
• Prepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes
• Support product development teams on regulatory issues, including review of documentation
• Provide regulatory assessments for anticipated design, manufacturing, and labeling changes

Job requirements

• Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred
• Minimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilities
• Knowledge of relevant Title 21 of the US code of Federal Regulations is required
• Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required
• Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required
• Experience with Quality Management System Standard ISO 13485 is required
• Experience with Risk Management Standard ISO 14971 is required
• Knowledge of EU MDR regulations is required