Principal Regulatory Affairs Specialist

Koninklijke Philips N.V • Murrysville, PA

1d • $114,750 - $205,632 • 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.

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 amodation 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 anding changes, facilitate/assist with interpretation to guide product and businesspliance 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 maintainpliance with global requirements.
• Identify areas for improvement for efficiency improvement andpliance in internal processes, work instructions, and forms. technical expertise to process improvement efforts.

Benefits

• Employees are eligible to participate in ourprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (withpany contribution), stock purchase plan, education reimbursement and .

What This Job Offers

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