Principal Regulatory Affairs Specialist

Philips • Murrysville, PA

25d • Onsite

About The Position

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 in the U.S., EU, and Rest of World 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.

Requirements

• You’ve acquired a minimum of 7+ years’ experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments.
• 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 a minimum of a Bachelors’ Degree (Required).
• 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.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

Nice To Haves

• RAPS certification- preferred.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees