Regulatory & Clinical Affairs Manager

COX-LITTLE & COMPANY; Princeton (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

COX-LITTLE & COMPANY is seeking a Regulatory & Clinical Affairs Manager in Princeton, NJ (onsite, open to relocation). This permanent, direct-hire role focuses on regulatory submissions for medical devices, including FDA 510(k), CE, and EU MDR, as well as strategies for SaMD/SiMD products.

The ideal candidate has 5–12 years of regulatory affairs experience in medical devices, with hands-on submission work and familiarity with ISO 13485, ISO 14971, and IEC 62304.

Qualifications

• Bachelor's degree in engineering, biomedical engineering, life sciences, regulatory affairs, or related field preferred.
• 5–12 years of experience in medical device regulatory affairs.
• Hands-on experience with FDA, CE, and EU MDR submissions; candidates should still be actively preparing submissions.
• Experience with 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 (ISO 13485, ISO 14971, IEC 62304).
• Experience with EU MDR and Technical Documentation submissions.
• Clinical affairs experience is a plus.

Responsibilities

• Prepare and execute regulatory submissions, including FDA 510(k) submissions and international registrations.
• 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.

Skills

Regulatory affairs

FDA submissions

CE/regulatory strategy

SaMD/SiMD

AI/ML in medical devices

Medical imaging/robotics

Education

Bachelor's degree in engineering / Biomedical Engineering / Life Sciences / Regulatory Affairs or related field

Tools

ISO 13485

ISO 14971

IEC 62304

EU MDR documentation

Job description

Position: Regulatory & Clinical Affairs Manager

Location: Princeton, NJ – Onsite (open to Relocating)

Type: Permanent / Direct Hire / Full Time

Primary Responsibilities:

• 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.

Qualifications:

• Bachelor’s degree in engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field is Preferred.
• 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