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Title: Regulatory Inquiry Expert (60)

Help transform Post Market Surveillance (PMS), which will help improve the lives of millions of people while advancing Philips’s journey as a global leader in Health Technology.

Your role
· Ensure timely and accurate responses to regulatory inquiries received from global Competent Authorities.
· Work with a variety of diverse persons within the Business Unit (Image Guided Therapy – Systems) such as Complaint Investigators, Business Experts, Clinical Experts, Market Experts, Vigilance Reporting Specialists, Engineers, Field Service & Application Engineers, and Manufacturing personnel to facilitate and develop responses to inquiries from regulators and competent authorities in accordance with written procedures and global requirements.
· Coordinate with Business Experts and reportable complaint investigators to determine the need for information required for the drafting of inquiry responses.
· Provide review of complaint to ensure all information needed for inquiry responses is present; determine if further investigation is needed and track investigation to conclusion.
· Write, track, and submit inquiry responses to the necessary authorities. Monitor and improve tracking/control systems for regulatory inquiry responses.
· Perform intake of new inquiries by logging data into tracker, complaint, Teams, and SharePoint.

You're the right fit if:
· You have a bachelor’s Degree or higher in biomedical engineering, science, healthcare, or medical profession (Associate’s degree may be considered for individuals with at least 5 years hands-on patient care experience or experience with servicing or supporting the product(s) or similar product(s) in the field).
· You have 4+ years’ experience Medical Device and/or other regulated industry. Experience in Post Market Surveillance in Medical device domain is preferred.
· You have 3+ years previous experience working as a biomedical engineer/risk manager/Quality and regulatory functions OR previous experience with servicing or supporting the product or comparable products in the field OR previous experience developing responses to regulatory inquiries.
· You have moderate understanding of Complaint Handling, CAPA, Corrections and Removals, as well as global medical device regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO13485, ISO14971, and ISO9001.
· You have a background in global post market surveillance regulations (21CFR, MDD93/42/EEC and other applicable global regulations).
· Your skills include great attention to detail, excellent writing skills, problem solving, ability to communicate issues in a timely manner, proficiency in Microsoft Office applications. Experience with Philips medical devices, Trackwise Complaint Handling Tool and Salesforce are a plus.
· You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position