Regulatory & Clinical Affairs Manager

PEAK Technical Services Inc.

Princeton, NJ

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JOB DETAILS

SALARY

$150,000–$185,000 Per Year

SKILLS

Academic Research, Artificial Intelligence (AI), Biology, Biomedical Engineering, Clinical Practices/Protocols, Clinical Support, Clinical Trial, Clinical Validation, Communication Skills, Data Collection, Documentation, Drug Development, Entrepreneurship, FDA (Food and Drug Administration), Healthcare Quality, Hospital, IRB/IEC (Institutional Review Board/Independent Ethics Committee), ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Internet Security, Leadership, Lift/Move 25 Pounds, Medical Equipment, Medical Imaging, Monitor Regulations, Organizational Skills, Product Development, Product Marketing, Product Support, Product Testing, Product/Service Launch, Project Schedule, Project Tracking, Project/Program Management, Publications, Regulations, Regulatory Requirements, Regulatory Submissions, Research Protocols, Risk Management, Robotics, Software Upgrades, Strategic Planning, Team Player, Technical Recruiting, Technical Writing, Validation Testing, Writing Skills

LOCATION

Princeton, NJ

POSTED

11 days ago

#Eng-IT-01
Regulatory & Clinical Affairs Manager
Location: Princeton, NJ
Status Direct Hire
Salary: $150,000 to $185,000
Experience: Bachelors Degree and 5+ years of experience in Medical Device and Regulatory

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.

Desired Characteristics

Collaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams.
Comfortable operating in a fast-paced, entrepreneurial medical device environment where responsibilities may evolve as the organization grows.
Strong learning agility and ability to quickly develop expertise in adjacent functional areas.
Comfortable taking ownership of new responsibilities beyond previous role boundaries.
Able to independently develop recommendations while seeking appropriate input from subject matter experts and leadership.

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, and lifting up to 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.

Regulatory & Clinical Affairs Manager

PEAK Technical Services Inc.

Princeton, NJ

About the Company

PEAK Technical Services Inc.

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