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Regulatory & Clinical Affairs Manager
Job in
Princeton, Mercer County, New Jersey, 08543, USA
Listed on 2026-10-15
Listing for:
COX-LITTLE & COMPANY
Full Time
position Listed on 2026-10-15
Job specializations:
-
Healthcare
Healthcare Compliance, Medical Science Liaison
Job Description & How to Apply Below
- Bachelor’s degree in engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field.
- 5-12 years of experience in medical device regulatory affairs
. - Hands-on experience on FDA, CE, EU MDR submissions - candidates themselves shall still be active in preparing the submissions, rather than serving only in a managerial or oversight capacity
- Experience with Software as a Medical Device (SaMD)/SiMD, AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products.
- Experience preparing and/or leading FDA 510(k) submissions
. - Experience supporting clinical studies, IRB submissions, or hospital-based research collaborations
- Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971, and IEC 62304
. - Experience with EU MDR and Technical Documentation submissions.
- Clinical affairs experience is a plus/nice to have
- Preparation and execution of regulatory submissions, including FDA 510(k) submissions, software modifications, and international registrations as applicable.
- Assess regulatory impact of software, AI/ML, cybersecurity, and product changes.
- Develop regulatory strategies and recommendations for new products and software upgrades.
- Support interactions with FDA, notified bodies, regulatory consultants, and international regulatory agencies.
- Monitor evolving regulatory requirements and communicate potential impacts to the organization.
- Support regulatory assessments related to design changes, risk management, verification, validation, and clinical
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