Senior Manager Regulatory Affairs

Sentec; Providence (RI); Hybrid; USD 135,000 - 165,000; Full time

Job summary

Sentec is seeking a Senior Manager of North American Regulatory Affairs to lead regulatory efforts for their products in the US and Canada. This role involves strategic planning, team management, and collaboration with internal and external stakeholders to ensure compliance and timely approvals. The position is hybrid, based in Lincoln, RI, and offers significant opportunities for professional growth within a rapidly expanding company focused on impactful healthcare solutions.

Benefits

Medical

Dental

Vision

HSA

FSA

401K matching

Paid parental leave

Wellness stipend

Tuition reimbursement

Qualifications

• Minimum of 10 years of experience in Regulatory Affairs for medical devices.
• In-depth knowledge of FDA and Health Canada regulations.

Responsibilities

• Develop regulatory strategy for product clearances.
• Manage a team of North American-based regulatory specialists.

Skills

Regulatory Affairs

Team Management

Strategic Planning

Job description

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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 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.

Responsibilities:

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 to define regulatory pathways
• Serve as the primary local representative and contact for the FDA, Health Canada, and other competent authorities

Internal focus

• Manage a team of North American-based regulatory specialists and managers
• Represent Regulatory Affairs on cross-functional project teams to develop regulatory strategies, testing requirements, and documentation to ensure timely approvals for new and modified products
• Support partner companies (suppliers, dealers) regarding regulatory issues as needed

Requirements

• Minimum of 10 years of experience in Regulatory Affairs for medical devices
• In-depth knowledge of the regulatory framework for medical devices, with specific expertise in FDA and Health Canada regulations; familiar with MDSAP audit program
• Experience managing direct reports with demonstrated ability to plan and manage cross-functional programs
• Prepared complete submission dossiers for at least two products or changes submitted 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 Lincoln, RI, with travel to Sentec facilities in North America and Switzerland as needed (anticipated 3-6 times annually)

Benefits

• Meaningful work in a rapidly growing company with opportunities for advancement
• Influence the quality of products and impact patient care worldwide
• Opportunities for professional and personal growth
• Salary: $135,000-165,000 plus bonus

Sentec offers competitive benefits including Medical, Dental, Vision, HSA, FSA, 401K matching, paid parental leave, wellness stipend, and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work, fostering a promising environment for professional growth. Our focus is on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you're not just taking a job — you're making a real impact by contributing to innovative medical solutions that support global wellbeing.

Sentec is a Swiss-American medical device company specializing in respiratory care. Founded in 1999, Sentec employs a deep-tech approach based on advanced science and cutting-edge technologies for respiratory patients across care areas. We provide healthcare professionals worldwide with non-invasive, continuous monitoring, and effective therapeutic solutions.

Seniority level

• Director

Employment type

• Full-time

Job function

• Legal

Industries

• IT Services and IT Consulting