Regulatory Affairs Manager-Medical Devices
Core
Lead global regulatory strategies and ensure compliance across the full lifecycle of medical devices, supporting product development, commercialization, and market access.
Role type
Senior Regulatory Affairs Manager (Medical Devices)
Builds
Medical device products and regulatory submissions for global markets
Domain
Medical Devices / Regulatory Affairs
Required skills
Global regulatory strategy, FDA submissions, international registrations, FDA/MDR/MDSAP frameworks, ISO 13485 QMS, leadership, stakeholder management, product lifecycle management, post-market compliance, design control, labeling review
Preferred skills
Class II/III device experience, RAC certification, CQA/CQE/Lead Auditor certifications
Technologies
FDA, MDR, MDSAP, ISO 13485
Responsibilities
Develop and implement global regulatory strategies; Provide regulatory leadership throughout product design, development, and post-market support; Advise executive leadership on regulatory risks and opportunities; Lead, mentor, and develop Regulatory Affairs team members; Oversee preparation and submission of regulatory filings; Ensure timely maintenance of product registrations; Manage communications with regulatory authorities and notified bodies; Integrate regulatory requirements into the Quality Management System; Participate in internal and external audits; Collaborate with Engineering to incorporate regulatory requirements into product designs; Review and approve product claims, labeling, and marketing materials; Monitor emerging regulations and industry best practices
Seniority
Senior, hands-on IC with leadership responsibilities