Regulatory & Clinical Affairs Lead, Med Devices

Healthcare Recruiters International; Princeton (NJ); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Healthcare Recruiters International is seeking a Regulatory and Clinical Affairs Manager in New Jersey. This role oversees regulatory submissions, safety and compliance activities, and clinical study coordination to support product development and regulatory approvals.

You will collaborate with engineering, QA, and clinical teams to ensure alignment with ISO, EU MDR, and FDA requirements, while managing multiple projects and timelines.

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 ISO 13485, ISO 14971, and IEC 62304.
• Experience with SaMD, AI/ML-enabled medical devices, digital health products.
• Experience with EU MDR and Technical Documentation submissions.
• Experience interacting with FDA, notified bodies, and clinical investigators.

Responsabilités

• Prepare regulatory submissions, including FDA 510(k) submissions and international registrations.
• Assess regulatory impact of software, AI/ML, cybersecurity, and product changes.
• Develop regulatory strategies for new products and software upgrades.
• Support interactions with FDA, notified bodies, regulatory consultants, and international agencies.
• Monitor evolving regulatory requirements and communicate impacts.
• Support regulatory assessments related to design changes and clinical evidence.
• Coordinate IRB submissions, clinical study protocols, and investigator documentation.
• Collaborate with hospitals, investigators, and academic partners on research.
• Develop clinical evidence for regulatory submissions, publications, and validation.
• Partner with engineering to ensure regulatory requirements are integrated into development.
• Collaborate with product management, marketing, clinical, and quality teams for commercialization.
• Manage multiple regulatory and clinical projects with schedules and deliverables.

Connaissances

Regulatory affairs

Clinical studies coordination

Technical writing

Project management

Cross-functional collaboration

Regulatory strategy

Communication skills

Product development liaison

Formation

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

Description du poste

Healthcare Recruiters International is seeking a Regulatory and Clinical Affairs Manager in New Jersey. This role oversees regulatory submissions, safety and compliance activities, and clinical study coordination to support product development and regulatory approvals.

You will collaborate with engineering, QA, and clinical teams to ensure alignment with ISO, EU MDR, and FDA requirements, while managing multiple projects and timelines.