Regulatory Affairs Specialist
1 day ago
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.
- 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).
- 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, 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, as well as 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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