# Regulatory and Clincial Affairs Manager

- **Company:** HealthCare Recruiters International
- **Location:** Princeton, 08540, US
- **Employment type:** FULL_TIME
- **Salary:** USD 140000 per year
- **Posted:** 2026-08-14T05:45:45+00:00
- **Apply:** https://hcrnetwork.com/job/regulatory-and-clincial-affairs-manager-princeton-nj/

## Description

Regulatory and Clinical Affairs Manager

Primary Responsibilities:


Regulatory Affairs


• 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 evidence.


Clinical Affairs & Hospital Collaboration


• Support preparation and submission of IRB applications, clinical study protocols, investigator


documentation, study reports, and publications.


• Coordinate collaborations with hospitals, physician investigators, and academic research


partners, and assist in organizing collaboration activities.


• Work closely with investigators and research coordinators to facilitate study execution, data


collection, and project tracking.


• Support development of clinical evidence for regulatory submissions, publications, and product


validation.


• Partner closely with engineering teams to ensure regulatory requirements are incorporated


throughout product development.


• Collaborate with product management, marketing, clinical, and quality teams to support


successful product commercialization.


• Independently manage multiple regulatory and clinical projects while maintaining schedules and


deliverables.


Qualifications:


• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or


related field.


• 5+ years of experience in medical device regulatory affairs.


• Experience preparing and/or leading FDA 510(k) submissions.


• Experience supporting clinical studies, IRB submissions, or hospital-based research


collaborations.


• Strong technical writing, project management, and communication skills.


• Experience working directly with engineering teams during product development.


• Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971,


and IEC 62304.


• Experience with Software as a Medical Device (SaMD), AI/ML-enabled medical devices, medical


imaging, surgical navigation, robotics, or digital health products.


• Experience with EU MDR and Technical Documentation submissions.


• Experience interacting with FDA, notified bodies, and clinical investigators.