Senior Manager Regulatory Affairs - Sentec

Sentec seeks an energetic and seasoned Senior Manager of North American Regulatory Affairs to lead North-American Regulatory Affairs for our portfolio of products in the United States and Canada. This position reports to the Global Head of Regulatory Affairs and Quality Assurance. Candidates should be versatile, self-driven individuals with a passion for patient care and strategic contribution in a small company environment. This position will work closely in conjunction with, and as an extension of, the Sentec AG Regulatory Affairs team based in Switzerland. This position is based in our Lincoln, Rhode Island office.

Key Tasks:

External focus

• Develop regulatory strategy for product clearances in conjunction with Sentec AG’s regulatory team.
• Compile submission dossiers for new product and changes to existing approvals in close cooperation with internal and external stakeholders (e.g. regulatory consultants).
• Lead FDA pre-submission, de-novo, breakthrough, pre-market authorization or similar activities as needed to define regulatory pathways.
• Serve as the primary local representative and contact to the FDA and Health Canada and other competent authorities.

Internal focus

• Manage team of North-American-based regulatory specialists and managers.
• Represent Regulatory Affairs on cross-functional project teams to develop regulatory strategies, testing requirements, and other documentation to ensure that regulatory submissions are prepared and approved to meet launch timelines for new and modified products.
• Support partner companies (suppliers, dealers) regarding regulatory issues as needed.

Your Profile:

• Minimum of 10 years of experience in a Regulatory Affairs position for medical devices.
• In depth knowledge of the regulatory framework for medical devices with specific expertise for FDA and Health Canada. Familiar with MDSAP audit program.
• Experience managing direct reports with demonstrated ability to plan and manage cross-functional programs.
• Have prepared complete submission dossiers for at least two products or changes to the FDA or Health Canada within the past 5 years.
• Experience with medical device quality, regulatory, and product realization processes.
• This is a Hybrid position based in our Lincoln, RI office. Travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times annually).

Our Offer:

• Meaningful work in a rapidly growing company with opportunity for advancement
• Directly influence the quality of products and make a difference for patients worldwide
• Opportunities for professional and personal growth

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.