Principal Regulatory Affairs Specialist

Job Description

Job Responsibilities:
u2022 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.
u2022 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.
u2022 Demonstrates substantial understanding of regulator's 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.
u2022 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.
u2022 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.
u2022 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.
u2022 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.
u2022 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.
u2022 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.
u2022 Disseminates specific regulatory requirements and memos, advising cross-functional teams on pertinent regulations, requirements, and standards to facilitate smooth business operations and market access.
u2022 Identifies and actively supports the implementation of site certifications to facilitate regulatory approvals and product endorsements, ensuring compliance with relevant regulatory requirements and standards.
u2022 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.
u2022 Provides expert guidance to product design teams on regulatory strategies and requirements for new products and solutions, including registrations, clinical evaluations, and risk assessments.
u00A0

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:

• Youu2019ve acquired a minimum of 14+ yearsu2019 experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments.

• Bachelorsu2019/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:

u2022 Regulatory Requirements
u2022 Document Auditing
u2022 Data Management
u2022 Regulatory Reporting
u2022 Product Registrations
u2022 Product Labeling
u2022 Strategy Implementation
u2022 Stakeholder Management
u2022 Regulatory Submission Documentation
u2022 Conformity Assessment
u2022 Regulatory Intelligence
u2022 Regulatory Compliance
u2022 Risk Mitigation Strategies
u2022 Continuous Improvement
u2022 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 companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. This is an Office-based role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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