Sr. Regulatory Affairs Principal

Job description

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 DeepHealths 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

As the Sr. Regulatory Affairs Principal this position will :

Develop and execute the regulatory strategy for DeepHealths 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 companys 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

Bachelors 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 FDAs 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

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

Remote. This position requires domestic / international travel up to 15%.

ACCOMMODATIONS

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

Salary Range :

$130K - $160K USD Annually

Notice for New York City Applicants :

For roles based in New York City RadNet / DeepHealth may use an Automated Employment Decision Tool (AEDT) to assist in candidate assessment. New York City residents may review the required AEDT notice bias audit summary and information on how to request an alternative process by contacting

Job requirements

Remote

• Somerville Massachusetts United States

$130000 - $160000

Compliance

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Required Experience :

Senior IC

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 130000 - 160000