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Regulatory Affairs Specialist
1 month ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Atrium Medical Corporation. The successful candidate will be responsible for ensuring compliance with regulatory requirements for domestic and international submissions/registrations.
Key Responsibilities- Assist the Regulatory Affairs Director with regulatory strategy/plans and requirements.
- Prepare worldwide regulatory submissions/registrations.
- Participate in the review and disposition of labeling, promotional materials and product modification.
- Prepare documentation and coordinate activities related to PMA's, 510k's, and IDE's.
- Support engineering changes through RA/QA practices by documenting the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations.
- Participate in cross-functional departmental team projects and product development activities/meetings.
- Provide support to RA Director for communication between Regulatory Agencies such as the Food and Drug Administration (FDA) and the European Notified Body.
- Responsible for FDA/ISO/MDD/CMDR compliance documentation.
- Assist in special projects as needed.
- Bachelor's Degree in Scientific/Engineering discipline.
- A minimum of three years experience in a regulatory environment.
- Willingness to handle a number of projects simultaneously in a fast-paced environment.
- Ability to assist in regulatory planning and strategies for domestic (510(k)/IDE/PMA) and international submissions/registrations.
- Ability to represent Regulatory Affairs to other departments.
