Global Regulatory Leader, Ambulatory Diagnostics

Philips; Cambridge (MA); On-site; USD 183,000 - 291,000; Full time

Benefits offered by this job

PTO (Paid Time Off)

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Head of Regulatory for Ambulatory Monitoring & Diagnostics to lead global regulatory strategy, ensuring compliance across development and commercialization. You will manage a team of Regulatory Affairs professionals and drive risk mitigation, submissions, and market access decisions.

The role requires extensive regulatory knowledge for medical devices, strong leadership, and the ability to influence senior stakeholders.

Qualifications

• Minimum 8+ years in regulatory affairs (or 6+ with master's) in the medical device field.
• People leadership experience is required.
• Experience authoring Class II 510(k) submissions; cardiology experience preferred.
• Bachelor’s or Master’s in Biomedical Engineering, Business, Health Sciences, Pharmaceutical, Law or equivalent; RAC preferred.

Responsibilities

• Develop and execute global regulatory strategies aligned with business goals.
• Lead and develop a global Regulatory Affairs organization.
• Oversee product registrations, CE Marking, and regulatory submissions across markets.
• Represent the company to regulatory authorities and key external stakeholders.
• Integrate regulatory requirements into product development and drive continuous improvement.

Skills

Regulatory strategy

Regulatory submissions

Leadership

Regulatory affairs

Education

Bachelor's degree in Regulatory Affairs

Master's degree in Regulatory Affairs

RAC certification

Job description

Philips is seeking a Head of Regulatory for Ambulatory Monitoring & Diagnostics to lead global regulatory strategy, ensuring compliance across development and commercialization. You will manage a team of Regulatory Affairs professionals and drive risk mitigation, submissions, and market access decisions.

The role requires extensive regulatory knowledge for medical devices, strong leadership, and the ability to influence senior stakeholders.