Regulatory Affairs Specialist

2 days ago

Atlanta, Georgia, United States Accordance Search Group Full time

Accordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Atlanta, GA.

The ideal candidate will have a strong background in regulatory affairs, with experience in developing global regulatory strategies for new and modified Class III devices. They will be responsible for providing regulatory guidance to cross-functional partners, preparing and submitting regulatory submissions in the US, EU, and outside of US geographies.

Key Responsibilities

  • Act as a regulatory representative on core product development teams, communicating regulatory requirements and impact of regulations to project teams.
  • Develop global regulatory strategies for new and modified products, ensuring compliance with 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and the IVD Directive (98/79/EC).
  • Prepare and submit PMA and IDE Submissions and Supplements, working with international affiliates to compile and submit international product registrations and licensing applications.
  • Interpret new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
  • Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
  • Maintain annual licenses, registrations, and listing information, and assist with compliance to product post-marketing approval requirements.
  • Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Review protocols and reports to support regulatory submissions.
  • Create, review, and approve engineering change requests.
  • Act as liaison between the Company and the various regulatory agencies, interfacing directly with FDA and Notified Bodies.

Requirements

  • Bachelor's Degree in a scientific discipline, such as Chemistry, Life Sciences, or Biology.
  • Experience in regulatory submissions for in vitro diagnostic devices and/or medical devices.
  • Experience working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).

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