Head of Regulatory, AM & D

Mass Digital Health; Massachusetts; On-site; USD 183,000 - 291,000; Full time

Benefits offered by this job

PTO

401k up to 7% match

Stock purchase plan

Job summary

Philips in the United States seeks a Head of Regulatory for Ambulatory Monitoring & Diagnostics to lead global regulatory strategy, liaise with authorities, and ensure compliance across product development and commercialization. You will oversee submissions, CE marking, and regulatory changes.

You will build a high‑performing global Regulatory Affairs team, drive market access, and partner with cross‑functional teams to integrate regulatory requirements. Travel up to 15% may be required.

Qualifications

• 8+ years of experience in Regulatory Affairs in medical devices (6+ years with a Master’s).
• Experience authoring Class II 510(k) submissions preferred.
• Strong knowledge of ISO 13485, 14971 and related standards.

Responsibilities

• Establish and execute the global regulatory strategy for the business by aligning regulatory, legislative, and competitive landscape insights with product and commercial objectives.
• Lead and develop a high-performing global Regulatory Affairs organization, providing direction, talent development, succession planning, performance management, and leadership.
• Drive regulatory compliance and market access across the product lifecycle, overseeing global product registrations, approvals, CE Marking, clinical evaluations, submissions, and change management.
• Serve as the primary representative to regulatory authorities, industry organizations, and key external stakeholders, building relationships and communicating regulatory developments.
• Partner cross-functionally to integrate regulatory requirements into product development and business processes, driving continuous improvement in regulatory outcomes.

Skills

Regulatory strategy

People leadership

Regulatory affairs

Clinical evaluations

Education

Bachelor's degree in Regulatory Affairs

Master's degree in Regulatory Affairs or related field

Tools

ISO 13485

ISO 14971

Job description

Job Title

Head of Regulatory, AM & D

Job Description

Head of Regulatory, Ambulatory Monitoring & Diagnostics

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.

Your role:

• 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:

• 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.
• Your skills include a 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.
• You have a Bachelor’s/master’s degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law or Equivalent. RAC certification preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an 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.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Chicago, IL, and Malvern, PA is $171,000 to $273,000.

The pay range for this position in Cambridge, MA is $183,000 to $291,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.