Regulatory Affairs Specialist I
Full Time/Permanent Position
Responsible for supporting FDA submissions and registration and renewal activities for medical products. Related duties, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and support of other regulatory work required to maintain domestic and international compliance.
• Responsible to provide support of guidance on domestic and international requirements, including:
- Review/Revise Regulatory Plans on regulatory requirements for FDA submissions for new products and significant post-market modifications as part of design input.
- Review/Revise Regulatory Determinations on FDA registration impact for significant product modifications as a design output.
- Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, IDE’s and PMA’s).
- Provide support materials for other country registrations.
- Assist with product renewal packages to maintain country registrations.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards.
• Responsible to review marketing and sign promotional materials for signature by management (as appropriate)..
• Responsible to review and sign labeling and Change Orders (as appropriate).
• Other assignments related to RA/QA to support requirements and priorities
Min Knowledge & Experience required for the position:
• Requires a bachelor’s degree, preferably in life sciences or engineering
• Familiarity with ISO 13485 and 14971 preferred
• Familiarity with the Medical Device Industry or other highly regulated environment.
• Experience with SAP is a plus but not required.