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Philips · 2 weeks ago

Principal Regulatory Affairs Specialist

Murrysville, PA

Full-time

Onsite

Senior Level, Lead/Staff

$115K/yr - $184K/yr

7+ years exp

Philips is a health technology company committed to improving healthcare access for everyone. The Principal Regulatory Affairs Specialist will develop and execute regulatory strategies for new product development and provide guidance throughout the design and development phases, focusing primarily on Software as a Medical Device (SaMD).

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

U.S. Citizen Only

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

Qualification

Regulatory Affairs StrategySoftware as a Medical Device510K submissionsEUMDR tech filesFDA regulationsIEC 82304IEC 81001-5-1ISO 27001Software Development LifecycleRAPS certificationStakeholder relationship building

Required

Minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments

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

Authored multiple 510Ks, with proven experience in EUMDR tech files, and Pre-Sub notifications submitted to the FDA

Familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations

Knowledge and understanding of the software development lifecycle (SDLC)

Minimum of a Bachelors' Degree

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

Ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation