Head of Regulatory, AM & D

Philips•Chicago, MA

5d•Hybrid

About The Position

The Head of Regulatory for Ambulatory Monitoring & Diagnostics will develop and execute global regulatory strategies aligned with business objectives, serving as the primary liaison between regulatory authorities and internal stakeholders while ensuring regulatory compliance across product development and commercialization. The role leads a team of Regulatory Affairs specialists, mitigates regulatory risks, oversees submissions and filings, and drives cross-functional integration of evolving global regulatory requirements.

Requirements

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.
Strong knowledge of relevant regulations and standards (ISO 13485, 14971, etc.).
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.
Bachelor’s/master’s degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or Equivalent.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Excellent communicator, with an ability to influence cross-functional stakeholders utilizing your clinical expertise and knowledge of standard of care and medical device standards.
Must be willing and able to travel up to 15% as required by business needs.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
For this position, you must reside in or within commuting distance to posted locations.

Nice To Haves

Cardiology experience is preferred.
RAC certification preferred.

Responsibilities

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.