The Regulatory Affairs Specialist will support all regulatory affairs activities worldwide. Will generate and assure compliance of regulatory submissions documents for new products or changes to existing regulatory submissions and/or approvals, and will generate reportable events to relevant authorities.
REPORTS TO: Director of clinical and regulatory affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Support preparation of worldwide regulatory strategies, submissions, registration and documentation
- Perform coordination and preparation of documents packages for regulatory submissions from all areas of the company (collaborate with Marketing, Clinical,
- R&D, Engineering and other departments as needed)
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Provide regulatory guidance for product’s requirements and changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Maintain Medical Device operations licenses for the relevant countries.
- Manage internal and external audits and inspections and provide post-audit follow-up information.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy and clarity of presentation.
- Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Evaluate current and new products for compliance with applicable regulations.
- Compile and maintain regulatory documentation databases.
- Review product complaints and reports to relevant regulatory authorities, as applicable.
- Maintain current knowledge base, identify, and interpret regulatory rules/guidance/ standards and ensure that they are communicated through corporate policies, procedures, work instructions.
- Review adverse device effects and file all related reports in accordance with regulatory agency guidelines.
- Write comprehensible, user-friendly, clear product information leaflets and labels.
- Initiate & maintain RA related SOP’s. Recommend changes to company procedures in response to changes in regulations or standards.
- Oversee risk management procedures.