Job Description

Job Title Senior Manager of North American Regulatory Affairs Company Sentec, a Swiss-American medical device company specializing in respiratory care, is seeking an energetic and seasoned professional 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. Location Lincoln, Rhode Island (Hybrid position, with travel to North America and Switzerland as needed) Responsibilities Develop regulatory strategies for product clearances in collaboration with Sentec AG's regulatory team. Prepare submission dossiers for new products and modifications to existing approvals, coordinating with internal and external stakeholders. Lead FDA pre-submission, de-novo, breakthrough, pre-market authorization, or similar activities. Act as the primary local representative to the FDA, Health Canada, and other authorities. Manage a team of North American regulatory specialists and managers. Participate in cross-functional project teams to develop regulatory strategies and documentation. Support partner companies regarding regulatory issues. Requirements At least 10 years of regulatory affairs experience in medical devices. Deep knowledge of FDA and Health Canada regulatory frameworks; familiar with MDSAP audits. Experience managing teams and cross-functional programs. Proven track record of preparing submission dossiers for FDA or Health Canada within the last 5 years. Knowledge of medical device quality, regulatory, and product realization processes. Benefits Competitive salary: $135,000 - $165,000 plus bonus. Comprehensive benefits including Medical, Dental, Vision, HSA, FSA, 401K matching, paid parental leave, wellness stipend, and tuition reimbursement. Opportunities for professional growth and making a meaningful impact on patient care. Additional Information Sentec emphasizes employee voices and recognizes hard work, fostering a promising environment for professional growth. Since 1999, Sentec has been dedicated to developing innovative respiratory healthcare solutions that improve patient wellbeing worldwide. #J-18808-Ljbffr

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