Senior Regulatory Specialist

Company

RadNet is a public company operating 350+ medical imaging centers across the US. Its AI division - comprising subsidiaries Aidence, DeepHealth, and Quantib - develops and markets AI-based software products for the early detection of breast, lung, and prostate cancers with the purpose of bringing the world's best doctor to every patient.

In the AI division, we are dedicated to addressing the most complex challenges faced by radiologists and enhancing their ability to focus on valuable tasks. Medical images hold the secrets to diseases that both physicians and we aim to unveil. Our mission is to empower radiologists with fast and accurate artificial intelligence software, enabling them to detect even the subtlest changes within the human body. If you're passionate about advancing healthcare through artificial intelligence, we invite you to join our team.

We are not just a workplace; it's a collaborative environment where teamwork is paramount. We're a close-knit, growing team, embracing an agile approach that allows us to swiftly adapt to challenges and opportunities alike.

Role Summary

The Sr. Regulatory Specialist is responsible for supporting DeepHealth'€™s product and product development and regulatory activities to commercialize new digital products, including AI technologies. In this role, the Sr. Regulatory Specialist 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 Senior Regulatory Specialist, this position will:

• Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.

• Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.

• Assist in SOP development and review in support of "next-gen" product offerings.

• Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

• Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.

• Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.

• Assist in preparation and review of regulatory submission to authorities.

• Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.

• Utilize technical regulatory skills to propose strategies on complex issues.

• Ensure compliance with product post marketing requirements.

• Review product labeling to ensure compliance with relevant regulatory requirements.

• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

• Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes.
  

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
Qualifications include:

• Bachelor'€™s degree in relevant field (or equivalent experience)
  

• Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
  

• 6-8 years working in a regulated industry (FDA and Software as a Medical Device preferred).
  

• Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings. Filings for Software as Medical Device preferred.
  

• Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus.
  

• Experience interacting with Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.
  

• 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

Working Conditions

This position is may be based in the United States, European Union, or India in a typical office setting.

This position will have the ability to work remotely.

Physical Requirements

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.

What We Offer

• Join a dynamic team with expertise in various fields.

• Collaborative and agile work environment.

• Continuous learning opportunities to enhance your professional skills.

• Fully remote working environment with Flexibility in work hours. 

• A salary in line with job level and experience.

* At this time, the company can only support visa sponsorship between European countries. We can not support visa sponsorship internationally between the US and Europe.

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