Our science-driven client is redefining expectations and advancing the field through cutting-edge solutions. The RA team is adding a Sr/Principal Regulatory Affairs Specialist to the team. The RA Specialist will report to the Director of RA and will lead and execute regulatory submission and approval activities for the company’s medical device products, with a primary focus on U.S. FDA submissions. This role will also provide support for international regulatory submissions outside North America. The Specialist will coordinate with FDA and international regulatory bodies throughout the submission and review processes to ensure timely approvals and ongoing compliance with applicable regulations and corporate standards. In addition, this role will support regulatory aspects of clinical studies.

Your role with the company:

• Drive regulatory planning and execution to ensure alignment with business and functional goals and priorities
• Prepare and review FDA submissions and other regulatory documents including 510(k)s, PMAs, PMA Supplements, PMA Amendments, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and periodic study reports as assigned
• Actively engage as the Regulatory Affairs representative on project teams
• Serve as a liaison with the Regulatory Agencies globally by conducting negotiations with agency reviewers as needed
• Review and interpret regulatory requirements as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
• Document review and approval to assure regulatory compliance (manufacturing process and product, change order, promotional review)
• Ensure that regulatory requirements are fully understood, implemented and/or mitigated in new product, clinical, marketing, and other business processes
• Communicate regulatory strategies and project status to internal stakeholders (Clinical Affairs, R&D, Marketing, Quality, Manufacturing)
• Interact with and influence external regulatory agencies and trade associations
• Author, review, and/or approve internal operating procedures related to regulatory affairs.
• Coordinate timely renewal of certificates, licenses, and global product registrations.
• Support Quality Assurance in maintaining ISO/CE Mark certifications and related regulatory audits.
• Participate in complaints process in assessing and reporting to appropriate agencies

Desired Profile:

• Bachelor’s degree in science or engineering required. Advanced degree is a plus.
• Minimum of 5 years of experience in Regulatory Affairs; 8+ years’ experience preferred
• Minimum of 5 years’ medical device industry experience including Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier, and HDE submissions.
• Experience with Global Regulatory Agencies (Notified Bodies, Competent Authorities, Health Canada, TGA) preferred.
• Class III medical devices experience required; cardiovascular experience preferred. Experience with tissue heart valves is a plus.
• Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
• Strong interpersonal, analytical, writing, and organizational skills, including the ability to find creative regulatory solutions in “grey” areas.
• Demonstrated ability in project management skills to plan, conduct and implement system assessments and robust submissions
• RAC Certification preferred.