Sr Regulatory Affairs Principal Autonomous

Hmixray; Somerville (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

A medical technology company in Somerville is looking for a Sr. Regulatory Affairs Principal. This role involves developing regulatory strategies for high risk FDA Class III products, leading submissions and ensuring compliance with global regulations. Candidates should have a strong background in regulatory affairs with 13-17 years of experience in a regulated environment. This position offers the flexibility to work remotely and requires excellent communication and leadership skills.

Qualifications

• 13 – 17 years working in a regulated industry, preferably FDA.
• Experience with US FDA Class III devices.
• Knowledge of Medical Devices Regulations (MDR) and ISO standards.

Responsibilities

• Develop regulatory strategy for FDA Class III devices.
• Lead regulatory submissions and manage compliance.
• Provide regulatory input on product lifecycle planning.

Skills

FDA Quality System Regulations knowledge

Regulatory filing experience

Excellent written and oral communication

Education

Bachelor’s degree in life science or engineering

Advanced degree or Regulatory Affairs Certification

Tools

Regulatory submission systems

Job description

Responsibilities

Job Title: Sr. Regulatory Affairs Principal (Autonomous)

Reports to: Head of Quality & Regulatory

FLSA Status: Exempt

Job Summary: Working cross-functionally with the Research and Development – ProFound team, the Sr. Regulatory Affairs Principal is responsible for developing and executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth’s high risk products, including AI technologies. This position will provide regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities.

Essential Duties and Responsibilities

• Develop and execute the regulatory strategy for DeepHealth’s high risk (FDA Class III) devices.
• Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for high risk medical devices.
• Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions.
• Work closely with business partners and regulatory team members to ensure compliance for and support of regulatory submissions and filings.
• Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company’s regulatory compliance, translating them into action steps for the organization.
• Create and ensure maintenance of technical documentation as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products

PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.

Minimum Qualifications, Education and Experience

• Bachelor’s degree in a life science, engineering, or related scientific field is required. An advanced degree or Regulatory Affairs Certification is preferred.
• 13 – 17 years working in a regulated industry (FDA and Software as a Medical Device preferred).
• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
• Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, Traditional 510(k) filings, and Premarket Approval for Software as Medical Device.
• Experience with US FDA Class III devices required; OUS device classification preferred.
• Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections. Experience with FDA’s Total Product Life Cycle Advisory Program (TAP) and Breakthrough Designation a plus.
• International submission experience in Australia, Canada, Brazil, and Japan for high risk devices.
• Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
• Knowledge and understanding of Medical Devices Regulations (MDR 2017/745, MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
• Excellent written and oral communication skills.

Quality Standards

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co‑workers, patients, visitors, and vendors.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
• Follows all local, state and federal laws concerning employment to include but not limited to: I‑9, Harassment, EEOC, Civil rights and ADA.
• Follows OSHA regulations, RadNet and site protocols, policies and procedures.
• Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
• Practices universal safety precautions.
• Promotes good public relations on the phone and in person.
• Adapts and is willing to learn new tasks, methods, and systems.
• Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with RadNet guidelines.
• Consistently adheres to the time management policies and procedures.
• Completes job responsibilities in a quality and timely manner.

Physical Demands

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.

Working Environment

This position is based in the United States in a typical office setting. This position will have the ability to work remotely.

NOTE: This position is not eligible for visa sponsorship.

ACCOMMODATIONS

Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.