Regulatory Affairs Specialist

As we continue to grow, we are actively seeking a new specialist to join our team and aid in maintaining compliance with important regulations and industry standards. At Interacoustics we are committed to creating innovative solutions that improve lives. Our values drive everything we do, and with an international and open-minded approach, we foster a culture of trust, flexibility, social engagement, and personal development opportunities while leveraging the latest technology stack to drive excellence in our products and services. You will be part of the Global Quality Department in Middelfart and report to the Vice President of Global Quality, Diagnostics. In your new job, you will immediately engage with regulatory affairs, and you will also ensure compliance with our existing product portfolio, delivering valuable information to the regulatory department ensuring the right external product registrations. A significant part of your role will be to provide assistance to internal stakeholders. You will also play an active role in guiding our many brands in relation to how they must deal with regulatory requirements and constant changes in a complex regulatory landscape, just as you oversee that the required activities take place, to ensure we are following current regulatory standards for medical device development. Among others, your key task will be: Provide regulatory support and assistance to Customer Service and other stakeholders Support registration in Eudamed, FDA database, and GUDID Ensure Technical Documentation (STED file) is prepared for all products, and handed over to Homologation Team Create, review and maintain regulatory documentation and labelling Ensure product changes are handled correctly from a regulatory standpoint Supporting legalization handling (apostille, notary and embassy) and handling of Free Sales Certificates Support in ensuring that new requirements are converted into actions You have experience of a similar position in an international company. You will be working with international markets, which makes it an advantage if you have worked with regulatory legislation outside Europe. You have strong knowledge and experience in ISO 13485 and MDR 2017/745 and you have also been involved in UDI and labelling. Your collaborative spirit and enjoyment in working alongside others will be essential as you connect with various team members throughout the organization. It is crucial that you are diplomatic and able to coordinate the activities of the people around you, and guide and advise the organization in finding solutions. Ensuring structure and being systematic comes of course to you. Our Culture: We offer a culture where clear communication, psychological safety, and empowerment is on the agenda and we encourage your personal development, through learning programs and courses. We value our colleagues' private life and offer flexible working hours and conditions. We have a friendly and caring culture where we always walk the extra mile to help and support each other so we succeed as a team. How to Apply: Please send us your application and CV as soon as possible and no later than April 27th 2025. Please note that we only accept application through our online recruitment system. We are curious to meet you! We will begin to invite candidates for interviews after the application deadline. The first-round interviews are scheduled for May 2nd, 2025. You can expect the final round of interviews to be held on May 8th 2025. For questions regarding the position, please contact. Flemming Vinding, Vice President Global Quality, Diagnostics, at flvi@dgs-diagnostics.com. At Interacoustics we are committed to creating an inclusive working environment. We welcome applications from all qualified candidates regardless of gender, age, ethnic origin and nationality. We look forward to hearing from you. Ansættelsestype: Permanent Hjemmearbejde: Not disclosed Ugentlig arbejdstid: Full-time Apply