Hiring: Head of Regulatory, AM & D Company: Philips Location: Cambridge, MA Job Posted Time: 2026-09-16 11:28:42 Employment Type: Full-time Target Skills & Keywords : Regulatory Compliance About the job Experience: •You’ve acquired 8+ years of experience with Bachelor’s, or 6+ years with master’s degree in Regulatory Affairs in the medical device industry. People leader experience is a must. Experience authoring class 2 510k submissions is a must, cardiology experience is preferred. •8+ years of experience with Bachelor’s, or 6+ years with master’s degree in Regulatory Affairs in the medical device industry. People leader experience is a must. Experience authoring class 2 510k submissions is a must, cardiology experience is preferred. Required Skills: •Head of Regulatory, Ambulatory Monitoring & Diagnostics •Establish and execute the global regulatory strategy for the business by aligning regulatory, legislative, and competitive landscape insights with product and commercial objectives. Serve as a trusted advisor to senior leadership, providing strategic guidance on regulatory risks, opportunities, and market access decisions. •Lead and develop a high-performing global Regulatory Affairs organization, providing direction, talent development, succession planning, performance management, and functional leadership to ensure regulatory excellence and organizational capability. •Drive regulatory compliance and market access across the product lifecycle, overseeing global product registrations, approvals, CE Marking, clinical evaluations, regulatory submissions, and change management activities to ensure timely commercialization and sustained compliance in international markets. •Serve as the primary representative to regulatory authorities, industry organizations, and key external stakeholders, building strong relationships, influencing regulatory policy discussions, negotiating approvals, and ensuring proactive communication of regulatory developments across the organization. •Partner cross-functionally to integrate regulatory requirements into product development and business processes, leading regulatory planning, risk assessments, and compliance strategies while driving continuous improvement initiatives that enhance operational efficiency, quality, and regulatory outcomes. •You're The Right Fit If •Your skills include a strong knowledge of relevant regulations and standards. Proven ability to represent a medical device company with competent authorities during audits and for responses is required. Experience with both new product development and sustaining activities is important. Qualifications: •You have a Bachelor’s/master’s degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or Equivalent. RAC certification preferred. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!