Sr. Regulatory Affairs Manager

Job Title
Sr. Regulatory Affairs Manager

Job Description

Senior Regulatory Affairs Manager (U.S. Hub based location)

The Senior Regulatory Affairs Manager will develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips Ultrasound.

Your role:

• Manage a team of around 5 direct reports working on both NPI and sustaining projects. Ability to provide mentorship to team members is important.
• Driving improvement in regulatory aspects of the Quality Management System (QMS) and in developing processes and documenting procedures to ensure an effective Quality System is maintained. Reviewing and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance.
• Providing 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, Canadian CMDCAS, Japan JPAL, compliance with FDA's guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally.
• Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements are determined to go into effect.
• Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols.
• Representing Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body

• You've acquired 7+ years of experience in a similar role within Regulatory Affairs in the medical device industry, with at least 3+ years of experience managing a team in a similar function. Hands on experience preparing submissions for new product introductions is required. Experience with 510(k) submissions and class 2/2a for EU required. Experiences surrounding international regulatory submissions and registrations required.
• Your skills include software as a medical device (SaMD), AI, and imaging devices experience strongly preferred. First line experience with US FDA and EU MDD/MDR required. Detailed knowledge of ISO 13485 and QSR registrations. Experience with successful preparation and submission of Technical Documentation, 510(k).
• You have a bachelor's degree or higher in a science, technical, or business discipline.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• You're an team player who can work in a matrixed environment with teams in different locations. 5-10% travel may be required, domestic and international.

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