Senior Regulatory Affairs Specialist

Your role:

• Serve as a Regulatory expert for 510(k) and CE Mark/EU MDR compliance, including interpretation and application of regulations, guidance, and standards across integrated hardware systems and complex device portfolios.
• Lead and influence global regulatory strategies to support market expansion and lifecycle management, with emphasis on system-level hardware integration considerations for US, EU, Japan, Canada, and other international markets as required.
• Provide regulatory leadership and strategic guidance to internal stakeholders (R&D, Quality, Clinical, Marketing, Manufacturing, Supply Chain, etc.) to ensure regulatory requirements are embedded into hardware system architecture, design inputs, verification, and validation activities.
• Drive preparation, review, and maintenance of EU MDR Technical Documentation, including oversight of conformity assessment activities and interactions with Notified Bodies.
• Partner closely with hardware and systems engineering teams to support regulatory assessments of system-level risk management and hazard analysis, hardware/software interfaces, design changes and impact assessments, and verification and validation strategies for integrated systems.
• Support and/or lead international regulatory submissions, registrations, and renewals, including coordination of submission strategies, gap assessments, and risk mitigation plans.
• Act as a key regulatory interface during Notified Body audits, regulatory inspections, and QMS audits, including preparation, participation, and follow-up activities.
• Provide regulatory input for post-market surveillance, vigilance, and change management, ensuring ongoing compliance throughout the product lifecycle.
• Mentor and provide technical leadership to other Regulatory Affairs professionals, supporting capability development and consistent regulatory execution.
• Communicate complex regulatory topics clearly and effectively to senior leadership and cross-functional teams, enabling informed decision-making on hardware design tradeoffs and system integration risks.

You're the right fit if:

• You've acquired a minimum of 7+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments including 510(k)s, PMA supplements, CE Marking/EU MDR Technical Documents, and pre-submissions.
• You have proven expertise/knowledge in Regulations/Standards for hardware (IEC 60601), Software (IEC 62304), Risk Management (ISO 14971) and experience with SaMD (IEC 82304) is preferred.
• You have familiarity with FDA, EU MDR, Health Canada, Japan and other relevant international regulatory standards, regulations, and submission paths.
• You have the proven ability to build strong relationships with internal and external stakeholders at all levels, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.
• You have a minimum of a Bachelors' Degree in Regulatory Affairs, a Scientific or Technical discipline. Master's Degree desired. RAPs RAC preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.