Head of Regulatory Affairs

We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting 510(k) notifications. This individual will lead regulatory strategy and submissions for devices requiring high standards of sterility, safety, and reliability. The Director will partner across R&D, Quality, Clinical, and Operations to ensure compliance with global regulations, support product development, and guide market expansion.

The ideal candidate will be skilled at navigating the regulatory complexities of invasive and combination products, ensuring the highest standards of patient safety while accelerating time to market.

• Leads the preparation, submission, and negotiation of 510(k) premarket notifications and EU MDR.
• Develops and implements global regulatory strategies for invasive medical devices across product life cycles.
• Serves as primary contact with the FDA and other global regulatory authorities.
• Provides regulatory guidance on design controls, risk management, biocompatibility, sterilization validation, and usability engineering.
• Provides regulatory guidance on post-market approval product design and process changes.
• Reviews and approves labeling, Instructions for Use, and promotional claims to ensure compliance with applicable regulations.
• Ensures compliance with regulatory requirements including FDA, QSR, ISO 13485, ISO 14971, IEC 60601, ISO 10993, and EU MDR.
• Collaborates with R&D and Clinical teams to support regulatory aspects of human factors testing and clinical investigations.
• Monitors post-market regulatory obligations, including vigilance reporting and
• Builds and maintains strong working relationships with regulators, notified bodies, and industry associations.
• Develops and mentors the Regulatory Affairs team, building expertise in invasive device submissions and lifecycle management.
• Ensures regulatory strategies are aligned with corporate objectives and communicated effectively to stakeholders.
• Prepares the organization for regulatory inspections and audits, ensuring documentation and processes are inspection-ready.

• B.S. in Regulatory Affairs, Life Sciences, Engineering, or related field.
• 10+ years of regulatory affairs experience in the medical device industry, with significant focus on invasive devices.
• Demonstrated success leading 510(k) submissions and managing FDA interactions.
• Strong working knowledge of regulatory requirements for invasive electromechanical devices, including sterility, biocompatibility (ISO 10993), and electrical/mechanical safety standards (IEC 60601), software and cybersecurity.
• Experience supporting clinical studies and integrating regulatory strategy into
• Knowledge of global regulatory requirements including FDA QSR, ISO 13485, ISO 14971, EU MDR, and post-market surveillance obligations.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong leadership, mentoring, and team development experience.
• Exceptional communication skills, with ability to influence at all levels of the organization.
• Ability to travel up to 25% domestically and internationally.

• Advanced degree or RAC (Regulatory Affairs Certification).
• Experience in other regulatory filings such as IDEs and PMA
• Experience with combination products (device + drug delivery).
• Knowledge of sterilization methods, packaging validation, and usability/human factors.
• Prior experience in high-growth, innovation-driven medical device companies.
• Experience working with international regulatory bodies and notified bodies.