regulatory inquiry expert.

You’re the Right Fit If You Have:

• Educational Background: A Bachelor’s Degree or higher in Biomedical Engineering, Science, Healthcare, or a related field (Associates degree may be considered for candidates with 5+ years of hands-on patient care experience or product servicing/support experience).
• Experience: At least 4 years of experience in Medical Device or another regulated industry. Post Market Surveillance experience in the medical device domain is a plus.
• Experience in Regulatory Roles: 3+ years of experience in biomedical engineering, risk management, quality, or regulatory functions. Alternatively, experience in servicing or supporting products in the field or developing responses to regulatory inquiries will also be considered.
• Regulatory Knowledge: Moderate understanding of Complaint Handling, CAPA, and global medical device regulations, including 21CFR Parts 803, 806, 820, ISO13485, ISO14971, ISO9001.
• Global Post-Market Surveillance: Background in global post-market surveillance regulations such as 21CFR, MDD93/42/EEC, and other applicable regulations.
• Skills: Strong attention to detail, excellent writing skills, and the ability to communicate issues timely and clearly. Proficiency in Microsoft Office applications is essential, with experience using Philips medical devices, Trackwise, and Salesforce as a bonus.