Principal Regulatory Affairs Specialist

Job Title

The Principal Regulatory Affairs Specialist will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep & Respiratory Care products

Your role:

• Author 510K submissions, pre-sub documents, EUMDR tech files, and will contribute to international regulatory submissions.

• Participate in strategic product development, design solutions starting from concept phase to product delivery phase and provide regulatory guidance throughout design and development.

• Act as a Regulatory Subject Matter Expert (SME) on various aspects and provide strategic guidance to other RA Staff and project team. Able to manage special projects across a spectrum of product lines.

• Monitor global regulatory landscapes and guide cross-functional teams on implementation of regulation changes.

• Communicate new and coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements.

• Supports product defect assessments, issue impact assessments, health hazard evaluations, corrections and removals and CAPAs as a regulatory SME.

• Review labeling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements.

• Identify areas for improvement for efficiency improvement and compliance in internal processes, work instructions, and forms. Apply technical expertise to process improvement efforts.

You're the right fit if:

• You’ve acquired a minimum of 14+ years’ experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments.

• Bachelors’/Master's Degree in Engineering in a related field

• You have proven expertise in Software as a Medical Device (SaMD), IEC 82304 (safety) and IEC 81001-5-1/ISO 27001 (Information Security).

• You have authored multiple 510Ks, with proven experience in EUMDR tech files, and Pre-Sub notifications submitted to the FDA.

• Your skills include familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations.

• You have knowledge and understanding of the software development lifecycle (SDLC).

• You have the proven ability to build strong relationships with internal and external stakeholders at all levels, sharing knowledge, providing regulatory insights, and ensuring alignment with regulatory requirements.

• Preferred Skills:

• Regulatory Requirements
• Document Auditing
• Data Management
• Regulatory Reporting
• Product Registrations
• Product Labeling
• Strategy Implementation
• Stakeholder Management
• Regulatory Submission Documentation
• Conformity Assessment
• Regulatory Intelligence
• Regulatory Compliance
• Risk Mitigation Strategies
• Continuous Improvement
• Project Management

How we work together

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-based role.

About Philips

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