Senior Regulatory Affairs Specialist
Job TitleSenior Regulatory Affairs Specialist
In this role, you have the opportunity to guide and support the business unit to ensure timely product registrations, regulatory planning for new product introductions and product changes, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
As a core member on product development teams, the Senior Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
- Work on issues where analysis of situations or data requires an in-depth knowledge of regulations and organizational objectives.
- Involvement in developing, modifying and executing company regulatory policies that affect immediate operations.
- Regular interaction with management and cross-functional teams to provide regulatory strategy at all stages of a products lifecycle.
Key Areas of Responsibility (KARs):
- Responsible for product registrations/approvals.
- Keep abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters.
- Recommend and develop strategies and create detailed written regulatory plans for:
- IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
- Traditional, abbreviated or special 510(k)s
- Pre-market Approval Applications
- Pre-submission applications
Worldwide product registrations
- Responsible for the coordination and preparation of document packages 510(k) pre-market notification and PMA applications, technical file and design dossiers for CE marking, and worldwide product registrations.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
- Provide audit support
- Provide guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA's guidance documents etc.
- Responsible for ensuring compliance with the current PCMS regulatory procedures and updating the procedures when new regulatory requirements become effective.
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- May represent Philips in an international committee chartered to develop an applicable standard.
- Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
- Coordinate testing required to support regulatory submissions.
- Strengthen and build clinical & regulatory capabilities.
- Mentor and coach junior BU regulatory members in their development.
- Maintain regulatory files and tracking databases as required.
- Must ensure that training assignments remain current.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree (Master's or Ph.D. preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
- RAPs RAC strongly preferred. ASQ certifications also desirable.
- Minimum of 6+ years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.).
- Experience with software products preferred.
- Must have personal experience with successful preparation and submission of 510(k) and/or PMA submissions.
- Strong background in Design Controls.
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
- Experience writing Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 highly desirable.
- Knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies.
- Experience in supporting international registrations and/or clinical investigations.
- Proficient computer skills in Microsoft Office.
- Understand LEAN concepts, methodologies and deployment.
- May require 5% travel annually with possibly some international.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that's not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role's mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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