Principal Regulatory Affairs Specialist

Overview

As a critical member of the Philips Ultrasound Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory oversight for critical new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA and other governmental agency/notified body regulatory compliance standards/requirements.

• Leads business critical new product development projects and provides regulatory oversight to maintain lifecycle requirements. Identifies risks within regulatory strategies and project plans, and outlines proposals for balancing project risks to project teams and RA management. Mentors and coaches Philips Ultrasound regulatory professionals in their development.
• Negotiates directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies) on regulatory filings at the reviewer level. All significant issues are reviewed with RA management.
• Drives improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained. Provides regulatory support for (pre-)clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
• Provides guidance on current, new and updated regulatory compliance procedures globally, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA guidance documents, and including requirements relevant to Philips Ultrasound priorities globally.
• As needed, represents Philips Ultrasound Regulatory Organization in internal audits and external audits by market regulatory agencies, including inspections and surveillance visits by Notified Bodies. May represent Philips in an international committee chartered to develop applicable standards.

• Minimum of 8+ years of Regulatory Affairs experience within FDA-regulated Medical Device/Health Tech product environments. Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired.
• Strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS, etc., with proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.
• 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 comparable disciplines (Required). Master’s degree and RAC Certification are desirable.
• Ability to perform the minimum physical, cognitive and environmental job requirements with or without accommodation.

We believe that we are better together than a part. 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 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 the posted ranges depending on factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. 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.

In addition, other…