Regulatory & Clinical Affairs Manager

#Eng-IT-01

Position Summary

Our client is seeking a hands-on professional to support the full regulatory lifecycle for innovative AI-enabled medical device software. This individual will prepare and execute FDA, EU MDR, and international regulatory submissions while partnering closely with engineering, quality, and clinical teams throughout product development.

Responsibilities

Regulatory Affairs

• Prepare, author, and execute FDA 510(k), software modification, and international regulatory submissions.
• Develop regulatory strategies for new products, software updates, and design changes.
• Assess regulatory impacts related to AI/ML software, cybersecurity, risk management, verification, and validation activities.
• Prepare and maintain EU MDR Technical Documentation and support CE Mark submissions.
• Interface directly with FDA, notified bodies, and international regulatory agencies.
• Collaborate with engineering teams to ensure regulatory requirements are incorporated throughout product development.
• Monitor evolving regulatory requirements and communicate business impacts.

Clinical Affairs

• Support preparation of IRB applications, clinical protocols, investigator documentation, study reports, and publications.
• Coordinate clinical collaborations with hospitals, physician investigators, and research partners.
• Assist with clinical evidence generation supporting regulatory submissions and product validation.
• Manage multiple regulatory and clinical projects while maintaining schedules and deliverables.

Qualifications

Required

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
• 5–10 years of medical device regulatory affairs experience.
• Demonstrated hands-on experience preparing and submitting FDA 510(k) submissions.
• Experience preparing EU MDR Technical Documentation and CE Mark submissions.
• Experience supporting Software as a Medical Device (SaMD), AI/ML-enabled medical devices, medical imaging, digital health, robotics, or surgical navigation products.
• Experience working directly with engineering teams throughout the product development lifecycle.
• Strong technical writing and project management skills.
• Knowledge of ISO 13485, ISO 14971, and IEC 62304.

Preferred

• Clinical affairs experience including IRB submissions, clinical studies, or hospital-based research collaborations.
• Experience interacting directly with FDA reviewers, notified bodies, and clinical investigators.

Benefits PEAK's benefit offerings available for our associates include medical, dental, vision, Flexible Spending Account (FSA), Dependent Care Savings Account (DCA), and 401K plan.PEAK believes that taking care of our team is essential for success and we are proud to provide benefits that enhance both your well-being and your future. Additionally, our associates may be eligible for Paid Sick Leave as required by Federal, State, or local laws. Equal Opportunity Employer (EEO) PEAK Technical Staffing is committed to creating a diverse and inclusive environment and is proud to be an Equal Opportunity Employer. PEAK does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status, or any other characteristic protected by applicable law. All employment decisions are made based on qualifications, merit, and business need. We encourage all individuals to apply. Americans Disabilities Act (ADA) The physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.Must be able to perform the essential physical functions of the position, including sitting, standing, walking, stooping, kneeling, andlifting upto 25 pounds, with or without reasonable accommodation. Candidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/and https://peaktechnical.com/ca-residents-privacy-rights/ AI Recruiting Disclosure We use AI-assisted tools to help review applications and compare your experience to job requirements, but all hiring decisions are made by human recruiters. You may request a human-only process or opt out of automated communication at any time. Required notices and our latest bias audit are available on our website: www.peaktechnical.com/ai-disclosure.