Regulatory Affairs Specialist

Main Duties: - Assist in the preparation, compilation and submission of premarket regulatory documentation, including EU IVDR submission, 510(k) submissions and other international filings, ensuring accuracy, completeness and adherence to regulatory requirements. - Review, maintenance and approval of technical documentation of the companys products, in compliance with the relevant regulations and standards. - Review complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products. - Assist in preparation, maintenance and approval of Risk Management and Post Market Surveillance Files. - Review and approval of artwork (labels, instructions for use) for compliance with applicable regulatory requirements and international standards. - Review change controls for impact on regulatory compliance. - Monitor changes in legislation, standards and guidance documents related to the companys products and communicate findings to cross functional teams as required. - Assist ...