Principal Regulatory Affairs Specialist

Overview

Principal Regulatory Affairs Specialist responsibilities with Philips Ultrasound Regulatory Affairs Organization include leading regulatory oversight for critical new product development projects to ensure FDA and other regulatory requirements are met.

Your Role:

• Lead business-critical new product development projects and provide regulatory oversight to maintain lifecycle requirements. Identify risks within regulatory strategies and project plans, outline proposals to balance project risks, and mentor Philips Ultrasound regulatory professionals in their development.
• Negotiate directly with regulatory enforcement entities on regulatory filings at the reviewer level. All significant issues are reviewed with RA management.
• Drive improvement in regulatory aspects of the Quality Management System and develop processes and documented procedures to maintain an effective Quality System. Provide regulatory support for (pre-)clinical studies, including strategies to optimize clinical study approvals and review of clinical study protocols.
• Provide guidance on current, new and updated regulatory compliance procedures globally, including CE Marking, product registrations, clinical evaluations (in accordance with MDD Annex X), ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, and FDA guidance documents applicable to Philips Ultrasound priorities globally.
• Represent Philips Ultrasound Regulatory Organization in internal audits and external audits by regulatory agencies, including inspections by Notified Bodies. May represent Philips in an international committee chartered to develop applicable standards.

• Minimum 8+ years of Regulatory Affairs experience in FDA-regulated Medical Device/Health Tech environments. Experience with SaMD and Ultrasound Imaging Devices is highly desired.
• Strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS, with proven experience in preparing and submitting Technical Documentation, 510(k), De Novo, PMA, and global device registrations.
• Ability to work in a large, matrixed organization and collaborate with globally dispersed partners/team members.
• Minimum Bachelor’s Degree in Regulatory Affairs, Engineering, Life Sciences or related disciplines (Required). Master’s degree and RAC Certification are desirable.
• Ability to perform the required Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.

We believe that we are better together. For office-based teams, in-person work is expected at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are typically conducted outside the main facilities, at customers’ or suppliers’ locations. This is an Office role.

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• The pay range for this position in Bothell, WA or Cambridge, MA is $128,520 to $205,632.

The actual base pay offered may vary within posted ranges based on factors including knowledge/skills, experience, business needs, location, and internal equity.

At Philips, top-end pay is not typical for most roles and compensation decisions depend on the facts of each case.

Other compensation may include annual incentive bonuses, sales commissions, or long-term incentives. Philips Total Rewards includes benefits such as PTO, 401k (up to 7% match), HSA (company contribution), stock purchase plan, education reimbursement, and more. Details about benefits are available.

• Company relocation benefits will not be provided. You must reside in or travel within commuting distance to the posted location.
• US work authorization is required. The company will not sponsor now or in the future.

This requisition is expected to stay active for 45 days but may close earlier if a candidate is selected or business needs dictate. Interested candidates are encouraged to apply promptly.

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