Current jobs related to Regulatory Affairs Specialist - Reedsville, Pennsylvania - Philips

Principal Regulatory Affairs Specialist - Ultrasound

We are seeking a highly experienced Principal 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 for complex new devices and post-market changes within our Ultrasound business.

• Lead Business-Critical Projects: Lead business-critical new product development projects, providing regulatory oversight to maintain a lifecycle ensuring that the state-of-the-art requirements are maintained.
• Develop Regulatory Strategies: 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.
• Regulatory Communication and Negotiation: Lead communication and negotiation efforts with regulatory enforcement entities on regulatory filings at the reviewer level.
• Global Compliance: 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, and including requirements that are relevant to the overall Philips Ultrasound priorities globally.
• Regulatory Procedures: Ensure compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect.
• Regulatory Support for Clinical Studies: Provide regulatory support for (pre)clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
• Internal and External Audits: Represent Philips in internal and external audits with regulatory agencies or Notified Bodies as needed.
• Mentorship and Coaching: Will Mentor and coach Philips regulatory professionals in their development; drive improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained.
• Collaboration and Communication: Reporting to the Director of Regulatory Affairs-Ultrasound, you will collaborate with regulatory Affairs team members globally, Engineering, R&D, Manufacturing and other cross-functional team members.
• Travel Requirements: This hybrid role may require travel up to 10%.

• Experience: A minimum of 7 years of experience in FDA-regulated Medical Device Regulatory Affairs, with proven expertise in U.S. FDA 510K, China NMPA, and EU MDR and International regulatory submission authoring experience required.
• Regulatory Expertise: A proven track record in the successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally.
• Software as Medical Device (SaMD) and Ultrasound Imaging Devices: Experience with Software as Medical Device (SaMD), and Ultrasound Imaging Devices (preferred).
• Global Regulatory Requirements: A strong understanding of all relevant global regulatory requirements, flexibility and adaptability to adjust to business needs, and strong communication skills.
• Education: A minimum of a Bachelor's degree (required) in Regulatory Affairs, a technical or business discipline, Advanced Degree (MS/PhD) - desired. RAC preferred.
• US Work Authorization: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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