About Regulatory Affairs Specialist Role Are you passionate about ensuring compliance and supporting business growth in the Medical Device / IVD industry? We're seeking a highly skilled Regulatory Affairs Specialist to join our team. Job Description: The successful candidate will provide regulatory support for new products and changes to existing products, ensuring efficient and compliant business processes. Key responsibilities include preparation of regulatory documents, product registration files submission, post-market maintenance support, change reviews coordination, complaint assessments, best practices identification and development within the Regulatory Affairs department. * Support the IDEM Business Unit with regulatory affairs activities related to product registrations worldwide including technical documentation updates. * Maintain records of submitted applications as well as handle any external audit findings by collaborating closely with various functions such as manufacturing sites quality teams supply planning customer service etc