Senior Manager Regulatory Affairs

at  ONWARD Medical

At ONWARD we’re looking for a Senior Manager Regulatory Affairs to join our team.
Full-time · Lausanne

• Act as PRRC (Person Responsible for Regulatory Compliance) per MDR Article 15
• Provide crucial regulatory support to the development team for the creation of a comprehensive Design History File and Technical Documentation.
• Collaborate closely with cross-functional teams, offering regulatory guidance in all aspects of product design, development, evaluation, labelling, and marketing.
• Oversee packaging and labelling requirements.
• Create Submission Files in accordance with 21 CFR 820 and with the General Safety and Performance Requirements (GSPR) checklist.
• Drive and coordinate FDA submissions, working closely with both internal teams and external consultants.
• Continuously assess the current regulatory activities against newly published guidance related to the Medical Device Regulation (MDR) and standards.
• Conduct traceability and compliance assessments to demonstrate adherence to applicable standards (e.g., 14708-1, 14708-3, IEC 60601-1), and collaborate with test houses as needed.
• Collaborate with the engineering team to execute Failure Modes and Effects Analysis (FMEA) in alignment with ISO 14971 requirements as part of technical file updates.
• Actively participate in ISO audits and provide valuable support to the Quality department in preparing for these assessments.
• Lead, mentor, and manage a team of Regulatory Specialists.