Sr. Manager, Regulatory Affairs

Work Schedule

Environmental Conditions

Role Description:
The Lead for Medical Device Regulatory Affairs will be responsible for, and will guide, regulatory activities supporting the full product lifecycle. The role combines hands-on execution with strategic regulatory expertise to provide precise, clear direction to teams. The Lead develops detailed regulatory strategies that align with company initiatives, ensure worldwide compliance, and deliver successful outcomes such as product registration, market launch, efficiency gains, and requirement fulfillment.

Responsibilities:

Lead the growth and development of a Quality & Regulatory team, strengthening capabilities across pre-launch and post-market phases to meet evolving business needs.
Guide and review regulatory dossiers (e.g., 510(k), PMA, CE marking, Technical Documentation/Files, and other global submissions) and drive them to approval.Serve as the primary liaison with regulatory authorities and Notified Bodies coordinate responses to queries, inspections, and audits to secure and maintain approvals.Lead post-market surveillance activities, including complaint handling, adverse event and vigilance reporting, field safety corrective actions, and periodic safety reports.Own regulatory data management (e.g., registrations, licenses, submissions, commitments, PMS data), ensuring data integrity, traceability, and timely renewals.Supervise document control and records management, ensuring alignment with QMS, regulatory, and internal governance requirements.Provide leadership for environmental and chemical compliance (e.g., RoHS, REACH, WEEE, and related regulations)Direct, support, and grow a dedicated Quality & Regulatory team establish clear targets, deepen functional knowledge, and build a reliable succession pipeline for critical roles.

Qualifications & Experience:

Bachelor's degree or equivalent experience in Life Sciences, Pharmacology, Engineering, Regulatory Affairs, or a related field advanced degree preferred.
15+ years of demonstrated expertise in medical device and/or IVD regulatory affairs with strong exposure to FDA and EU MDR/IVDR and other key global markets.Deep knowledge of medical device compliance requirements and standards (e.g., IEC 61010-1/60601-1, EMC standards, usability/human factors, software lifecycle standards).Proven track record of successful regulatory strategies, submissions, and approvals across multiple regions and product types, specifically IVDs.Strong understanding of global regulatory frameworks, QMS principles (e.g., ISO 13485), and post-market/vigilance expectations.Confirmed leadership experience building and managing teams strong influencing, collaborator management, and decision-making skills.Excellent written, verbal, and presentation skills, with the ability to communicate regulatory issues in clear business language.Strong interpersonal, planning, and follow-through capabilities able to handle multiple priorities in a fast-paced environment.Professional certification such as RAC (or equivalent) preferred.High adaptability, resilience, and facilitation skills able to lead cross-functional teams, drive alignment, and deliver results under time pressure.