[ref. i05759316] Lincoln - Senior Manager Regulatory Affairs

This position is based in our Lincoln, Rhode Island office.

Responsibilities:

• 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.

• 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

• 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)

• 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
• Salary: $135,000-165,000 plus bonus

Sentec focuses on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you’re not just choosing a job – you’re embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide.

Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.