Regulatory & Clinical Affairs Manager
Position Summary:
There is a Regulatory & Clinical Affairs Manager position available at EDDA Technology, Princeton, NJ.
The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company’s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations.
This position is intended for a motivated professional seeking to grow into increasing levels of responsibility within a dynamic medical device environment. The successful candidate will be expected to independently manage assigned projects and develop well-reasoned regulatory recommendations, while working closely with cross-functional teams on overall regulatory and clinical strategy.
This role offers significant opportunities for professional growth, increased ownership, and direct exposure to executive-level strategic planning, regulatory agency interactions, and clinical partnerships.
The position combines regulatory affairs, clinical affairs, and hospital collaboration activities, supporting innovative AI-enabled medical imaging, surgical planning, surgical navigation, and digital health technologies.
Primary 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.
Cross-Functional Collaboration
- 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:
- 5-10 years of experience in medical device regulatory affairs.
- Experience preparing and/or leading FDA 510(k) submissions.
- 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.
- Familiarity with medical device quality systems and standards, including ISO 13485, ISO 14971, and IEC 62304.
- 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.
- Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field.
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.
Company Introduction:
Excellent opportunity with a dynamic, growing medical technology solution company.
EDDA Technology is an innovative leader in the rapidly growing field of intelligent robotic solutions for precision surgery. Pioneering a “fully quantitative, interactive” approach to intelligent imaging analytics and robotic integration, the company has built a proprietary technology platform to facilitate pre-surgical planning and simulation, intra-operative navigation, post-operative evaluation. With its end-to-end enabling platform, EDDA’s goal is to form a comprehensive ecosystem of clinical practice, connection, and education to support physicians and patient management in all tiers of hospitals. IQQA® is a registered trademark of EDDA Technology. (www.eddatech.com)
Compensation/ Benefits
Salary Range: $140,000 - $190,000; compensation is based on experience, education, and relevant skills.
EDDA offers a competitive salary, performance-based incentive stock options, and excellent benefits including medical and dental insurance, vision care, 401k plan, section 125 health and dependent care (flexible spending) accounts, and paid vacations. The company sponsors the H1-B application.
Send applications to: [email protected]
Pay: $140,000.00 - $190,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Paid time off
- Parental leave
- Referral program
- Vision insurance
Application Question(s):
- How many years of work experience do you have with ISO 13485?
- How many years of work experience do you have with ISO 14971?
- How many years of work experience do you have with IEC 62304?
- How many years of experience do you have in medical device regulatory affairs?
- How many years of experience do you have in preparing and/or leading FDA 510(k) submissions?
- How many years of experience do you have in supporting clinical studies, IRB submissions, or hospital-based research collaborations?
- How many years of work experience do you have with AI/ML-enabled medical devices, medical imaging, surgical navigation, robotics, or digital health products?
- How many years of work experience do you have with EU MDR and Technical Documentation submissions?
- How many years of work experience do you have with FDA, notified bodies, and clinical investigators?
- Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?
- Are you legally authorized to work in the United States?
- How many years of work experience do you have with SaMD/SiMD submissions?
Ability to Commute:
- Princeton, NJ 08540 (Required)
Work Location: In person
