Senior Manager Regulatory Affairs

Sentec; Lincoln (RI); On-site; USD 135,000 - 165,000; Full time

Job summary

Sentec is looking for a Senior Manager of North American Regulatory Affairs to lead regulatory strategies for medical devices. This role requires extensive experience in regulatory affairs, team management, and collaboration with internal and external stakeholders, ensuring compliance with FDA and Health Canada regulations. The position offers opportunities for professional growth and impactful work in improving patient care globally.

Benefits

Medical

Dental

Vision

HSA

FSA

401K matching

Paid parental leave

Wellness stipends

Tuition reimbursement

Qualifications

• At least 10 years of experience in Regulatory Affairs for medical devices.
• Proven experience preparing submissions for FDA and Health Canada within the last 5 years.

Responsibilities

• Develop regulatory strategies for product approvals in collaboration with Sentec AG's regulatory team.
• Lead interactions with FDA, Health Canada, and other authorities.

Skills

Regulatory Affairs

Team Management

Cross-Functional Collaboration

Job description

Job Title: Senior Manager of North American Regulatory Affairs

Sentec is seeking an energetic and experienced Senior Manager of North American Regulatory Affairs to lead regulatory strategies for our products in the United States and Canada. This role reports to the Global Head of Regulatory Affairs and Quality Assurance and involves close collaboration with our Swiss-based Regulatory Affairs team. The position is based in Lincoln, Rhode Island.

Responsibilities

External Focus

• Develop regulatory strategies for product approvals in collaboration with Sentec AG's regulatory team.
• Prepare submission dossiers for new products and modifications, working with internal teams and external stakeholders.
• Lead interactions with FDA, Health Canada, and other authorities, including pre-submission activities.

Internal Focus

• Manage a team of regulatory specialists and managers in North America.
• Participate in cross-functional teams to develop regulatory strategies and documentation for product launches.
• Support partners regarding regulatory issues as needed.

Requirements

• At least 10 years of experience in Regulatory Affairs for medical devices.
• Deep knowledge of FDA and Health Canada regulations; familiar with MDSAP audits.
• Experience managing teams and cross-functional projects.
• Proven experience preparing submissions for FDA and Health Canada within the last 5 years.

Benefits

• Opportunity to work in a growing company with advancement potential.
• Impactful work that improves patient care globally.
• Professional and personal growth opportunities.
• Salary range: $135,000 - $165,000 plus bonus.

Sentec offers competitive benefits, including Medical, Dental, Vision, HSA, FSA, 401K matching, paid parental leave, wellness stipends, and tuition reimbursement. We value employee voices and support professional development.

Join Sentec to contribute to innovative healthcare solutions that support patient wellbeing worldwide. Sentec is a Swiss-American company specializing in respiratory medical devices, committed to advanced science and technology.

Additional Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Legal
• Industry: IT Services and Consulting