Regulatory Affairs Specialist

4 days ago

Atlanta, Georgia, United States Accordance Search Group Full time
Principal Regulatory Affairs Specialist

Accordance Search Group is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in Atlanta, GA. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices, and 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, and providing input related to FDA and international product registrations and licensing requirements.
  • 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 (or equivalent vocational qualifications).
  • 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).
Preferred Qualifications
  • 5-7 years' experience in a regulated industry with a minimum of 3 years directly related to Class III Medical Devices.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Ability to work effectively on project teams.
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Strong written, verbal, presentation, and organizational skills.
  • Strong analytical and problem-solving skills.
  • Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
  • Experience with medical device software requirements and software regulations.
  • Ability to identify risk areas and escalate issues as appropriate.

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