Regulatory Affairs Manager.
The Regulatory Affairs Manager is responsible for working with domestic and international regulatory agencies and internal personnel to obtain and maintain product approvals and uphold regulatory compliance. The Regulatory Affairs Manager will participate in all phases of the device lifecycle, from design, development, and device approval to post-market surveillance.
This position reports to the Sr. Director Regulatory Affairs.
Essential Duties & Responsibilities
- Contribute to and develop regulatory strategies to ensure applicable global requirements are met.
- Prepare timely and compliant submissions to domestic and international regulatory agencies (510(k), IDE, PMA, HDE, IND, BLA, CE dossiers, supplements, responses, state licensure/certifications, export certifications, product registrations, etc.).
- Identify, collect, review, and evaluate information critical to submission packages.
- Complete regulatory assessments of product modifications and ascertain impact on current regulatory approvals.
- Support activities to implement and maintain EU MDR 2017/745 and UK MDR requirements.
- Interpret regulations and related information for Research & Development, Operations, Quality Assurance, and Marketing.
Evaluate and recommend changes to labeling, marketing literature, and clinical protocols for regulatory compliance to recognized laws or regulations.
- Communication with responsible regulatory authorities and distributors (domestic/international).
- Interact with regulatory agencies as part of submission review and on-site audit support.
- Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, and the quality system as applicable to the responsibilities outlined with this job description.
- Develop, review, and support maintenance of regulatory SOPs.
- Collaborate with cross-functional teams.
Minimum Bachelor’s degree in a scientific discipline
Experience and Skills
Work Experience Required:
- Minimum of 5 years’ experience in medical device Regulatory Affairs
Specialized Skills, Knowledge:
- Excellent written and oral communication skills
- Experience in preparation of U.S. submissions and Design Dossier applications
- Proficient in pertinent software & tools
- Strategic-minded, analytical and detail-oriented
- Ability to work independently and as part of a team
- RAC certification preferred
The physical demands of this position are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will be based at the Roswell, GA facility.
Some travel may be required as the needs of the business dictate.