Regulatory Affairs Specialist

Demant

Middelfart, Syddanmark
Permanent
Fuldtid

17 dage siden

We are on an exciting path of growth and are currently seeking a new specialist to join our team and play a crucial role in ensuring that our operations adhere to relevant 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 impact regulatory affairs, future product development and launch, just as you will also ensure compliance on 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 take regulatory ownership of selected product areas, and ensure the required activities take place, to ensure we are following current regulatory standards for medical device development. Working side-by-side with our developers and regulatory compliance team members, you will be responsible for and delivering:Among others, your key tasks will be:

Ensuring regulatory classification and strategy is executed on selected product areas
Representing regulatory affairs in product development projects, and work close together with our regulatory compliance department
Creating and maintaining regulatory documentation
Ensuring alignment with the team handling product registrations
Providing regulatory assistance to Customer Service and other stakeholders
Collaborating with cross-functional teams to integrate regulatory requirements into business processes

You have experience of a similar position in an international company with responsibility for regulatory affairs within a related product area.You have a proven knowledge and experience in ISO 13485 and MDR 2017/745 and hopefully have been I touch with UDI and labelling.As a person you have a positive mindset and enjoy working with others as you will be collaborating with many different colleagues across the organization. It is crucial that you are diplomatic and able to coordinate the activities of the people around you. Ensuring structure and being systematic of course comes natural 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:Send your application using our recruitment system. The deadline for applying is the 10th of June, but applications are evaluated continuously. For questions regarding the position, please contact Flemming Vinding, Vice President Global Quality, Diagnostics, at . For questions regarding the recruitment process or our company, please contact Debbie Nielsen at .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.#LI-DM213 May 2024Middelfart, DK, 5500InteracousticsInteracoustics is a world leading diagnostic solutions provider in the field of hearing and balance assessment. We design, manufacture and sell products across the whole audiological spectrum, from small portable devices to full clinical instruments. Our products are sold in more than 100 countries through our extensive network of sales companies and distributors.Interacoustics employs more than 200 people at the head office in Middelfart, more than 500 worldwide and is among the world's leading suppliers of audiological equipment.Interacoustics is part of the Demant Group. This group of international companies develops, manufactures and markets a wide variety of technological solutions, ranging from state-of-the art digital hearing instruments and assistive listening devices to revolutionary new diagnostic systems.

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