Principal Regulatory Affairs Specialist

Job Responsibilities:
Contributes to the development and implementation of regulatory strategy and roadmaps by demonstrating good understanding of the competitive market landscape, regulatory and legislative initiatives, and product marketing strategy to ensure alignment with business goals and compliance requirements. Works under limited supervision, contributes to development, modification, and execution of organizational policies and directs regulatory resources to ensure timely product registrations, plan regulatory requirements for new product introductions and changes, and maintain ongoing compliance throughout the product lifecycle. Demonstrates substantial understanding of regulators role in the Quality System with good awareness of product lines, disease states, and customers, possessing comprehensive knowledge of business developed through education or past experience. Applies advanced and wide-ranging knowledge and varied concepts in area of specialization to address challenges for a business and executes comprehensive global regulatory strategies and roadmaps by analyzing the competitive market landscape, regulatory initiatives, legislative changes, and aligning them with the overall product marketing strategy. Networks with key contacts outside own area of expertise and maintains strategic partnerships with external/internal stakeholders, fostering collaboration and information exchange to drive innovation and business growth. Handles all product registrations and approvals, ensuring that products meet the necessary regulatory requirements for various markets and that approval processes are completed efficiently and accurately. Coordinates regulatory resources to guarantee timely product registrations, strategic regulatory planning for new product introductions and changes, and the maintenance of ongoing regulatory compliance across all product lines. Advises product design teams on regulatory strategy and specific requirements for new products and solutions, guides the entire process of product registrations and approvals, ensuring compliance with global regulatory requirements to facilitate timely market entry and continued market presence. Provides the regulatory plan and offer comprehensive guidance on risk assessment and required corrective actions to meet regulatory requirements, while delivering leadership and direction on global regulatory strategy, such as marking, product registrations, and clinical evaluations. Disseminates specific regulatory requirements and memos, advising cross-functional teams on pertinent regulations, requirements, and standards to facilitate smooth business operations and market access. Identifies and actively supports the implementation of site certifications to facilitate regulatory approvals and product endorsements, ensuring compliance with relevant regulatory requirements and standards. Offers guidance on global regulatory strategy, including CE Marking and clinical evaluations, while providing regulatory plans, risk assessments, and corrective action guidance to ensure compliance with all regulatory standards. Provides expert guidance to product design teams on regulatory strategies and requirements for new products and solutions, including registrations, clinical evaluations, and risk assessments.

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.

Youre the right fit if:

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

• Bachelors /Masters 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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