Regulatory Affairs Specialist

2 weeks ago

Pune, Maharashtra, India Randstad Digital Full time ₹ 15,00,000 - ₹ 20,00,000 per year

Job Title: Sr. Regulatory SpecialistLocation: Pune/BangaloreExperience:5-8YearsJob Description:As the Sr. Regulatory Specialist, this position will:Must Have:(SaMD product experience)

  • 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 Deep Health 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 Deep Health products and product changes.
  • Ensuring timely submission of adverse events to the appropriate regulatory bodies.

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. Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. 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 US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.

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