Regulatory Affairs Specialist

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips. As a key member of our Regulatory Affairs team, you will play a critical role in preparing comprehensive regulatory strategies and post-market changes for complex, new/existing Ultrasound systems/devices.

Key Responsibilities

• Develop regulatory strategies and communicate risks within regulatory strategies vs project plan, and outline proposal for balancing the project risk to project teams and Regulatory Affairs Management.
• Lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained.
• Mentor/coach Philips regulatory professionals; drive improvement in regulatory aspects of the Quality Management System, in developing/documenting processes and procedures to maintain an effective Quality System.
• Lead communication/negotiation with regulatory entities on regulatory filings at the reviewer level.
• Provide guidance on global compliance such as CE Marking and product registrations, clinical evaluations in accordance with EU MDR, ISO 13485, and ISO 14155, China NMPA, Canada, Japan JPAL, compliance with FDA's guidance documents, requirements and procedures when new regulatory requirements are determined to go into effect.
• Represent Philips in internal/external audits with regulatory agencies or Notified Bodies.
• Provide regulatory support for (pre) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.

Requirements

• A minimum of 7 years' experience in Regulatory Affairs within FDA regulated Medical Device, with expertise in the Preparation, Authoring and Submission of 510K's, PMA, China NMPA, De Novo, Technical Documentation, and EU MDR /International regulatory submissions/registrations required.
• Proven experience with Software as Medical Device (SaMD), and Ultrasound Imaging Devices (preferred).
• A strong understanding of all relevant global regulatory requirements, flexibility and adaptability to adjust to business needs, and strong communication skills.
• A minimum of a Bachelors degree (required) in Regulatory Affairs, a technical/Engineering or business discipline.

About Philips

We are a health technology company built 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.