Stellenbeschreibung
Senior Manager Global Regulatory Affairs
Standort:
Radolfzell, DEU
Stellenbeschreibung:
TASKS
At NDI, our measurement technologies support medical procedures and help improve patients’ lives. As Senior Manager of Regulatory Affairs, you will lead global regulatory strategy and execution for NDI’s product portfolio and broader product compliance. You will develop the team and work across Quality, R&D, Operations, Commercial, Clinical and Product Management to support international market access and business growth.
- Lead global market access and lifecycle compliance across NDI’s product portfolio, addressing all applicable international regulatory requirements.
- Lead and develop NDI’s Regulatory Affairs team members in Canada, US and Germany, set priorities, plan resources and manage approved budgets and external expertise.
- Oversee submissions, registrations, technical documentation, labeling and change assessments. Coordinate regulatory reviews and required approvals during development and before release, including radio equipment requirements such as RED where applicable.
- Lead regulatory intelligence and cross-functional implementation of new requirements, including applicable product, materials and packaging obligations such as PPWR, RoHS and REACH.
- Oversee regulatory reporting, post-market surveillance and regulatory coordination of recalls, field safety corrective actions and field safety notices, as applicable.
- Lead engagement with regulatory authorities and notified bodies; provide regulatory guidance and appropriate compliance evidence to OEM customers integrating NDI technologies.
- Advise senior leadership on regulatory risk, launch readiness and investment needs; improve regulatory processes across assigned products and sites.
- This role requires strong regulatory expertise in a complex and evolving global medical device environment.
- The ideal candidate demonstrates thorough knowledge of U.S. FDA medical device regulations - particularly 21 CFR Part 820 QMS, 21 CFR 803, 21 CFR 806, and complaint handling - as well as international standards, including ISO 13485 and ISO 14971.
- Familiarity with European Union Medical Device Regulation (EU MDR 2017/745), Canadian Medical Device Regulations (SOR/98-282), UK Medical Device Regulations, Switzerland’s medical device requirements, Japanese Ministerial Ordinance No. 169, and South Africa’s regulatory framework is expected.
- These capabilities ensures product and system compliance, sustained market access, and consistently high standards for quality and patient safety. Comprehensive understanding of regional regulations, registration pathways, and ongoing vigilance for regulatory changes is critical for success in this role.
PROFILE
- A degree in science, engineering or a related discipline, or equivalent relevant education and experience.
- 10 or more years in medical-device regulatory affairs, with at least 5 years leading teams or major regulatory programs, with demonstrated success in managing and developing people. Strong FDA and EU MDR experience, knowledge of other international regulatory frameworks and experience with sterile medical devices. Ability to address requirements across medical devices, OEM components and broader product compliance.
- Proven leadership, strategic planning and stakeholder management skills, with sound regulatory judgment and a record of delivering cross-functional change.
- RAC certification, OEM component experience, multi-site leadership and broader product compliance expertise are assets.
- Experience applying AI tools to regulatory work with appropriate human review, confidentiality controls and compliance with approved procedures.