Regulatory and Clincial Affairs Manager
healthcare recruiters internationalPrinceton (NJ)
Regulatory and Clincial Affairs Manager
Posted 54 days ago
healthcare recruiters internationalPrinceton (NJ)
SENIORITY
Manager
About the role
Regulatory and Clinical Affairs Manager
Primary Responsibilities:
- Regulatory Affairs
- Preparation and execution of regulatory submissions, including FDA 510(k) submissions, softwaremodifications, 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 internationalregulatory 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, investigatordocumentation, study reports, and publications.
- Coordinate collaborations with hospitals, physician investigators, and academic researchpartners, and assist in organizing collaboration activities.
- Work closely with investigators and research coordinators to facilitate study execution, datacollection, and project tracking.
- Support development of clinical evidence for regulatory submissions, publications, and productvalidation.
- Partner closely with engineering teams to ensure regulatory requirements are incorporatedthroughout product development.
- Collaborate with product management, marketing, clinical, and quality teams to supportsuccessful product commercialization.
- Independently manage multiple regulatory and clinical projects while maintaining schedules anddeliverables.
Qualifications:
Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, orrelated 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 researchcollaborations.
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, medicalimaging, surgical navigation, robotics, or digital health products.
Experience with EU MDR and Technical Documentation submissions.
Experience interacting with FDA, notified bodies, and clinical investigators.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.