Regulatory Affairs Specialist

Are you ready to make a significant impact on the future of medical devices? Join Interacoustics, a company committed to creating innovative solutions that enhance lives globally. We are on an exciting path of growth and seek a skilled Regulatory Affairs Specialist to ensure our operations comply with relevant regulations and industry standards.

About Us
Interacoustics has been a global leader in diagnostic hearing and balance solutions for over 50 years. Helping people overcoming their hearing and balance challenges has been part of our DNA from the beginning. Our values are the cornerstone of everything we do. We are committed to maintaining a culture of trust, flexibility, and personal growth, leveraging innovative technology to deliver innovative products and services. We thrive in a vibrant international environment that encourages open-mindedness and social engagement.

Your Role
Based in Middelfart, you will join our Global Quality Department and report to the Vice President of Global Quality, Diagnostics. As a Regulatory Affairs Specialist, you will take ownership of regulatory affairs for selected product areas, ensuring adherence to current regulatory standards, as well as represent regulatory affairs in product development projects, collaborating closely with our regulatory compliance department.

Your job will also involve creating and maintaining regulatory documentation, ensuring alignment with product registration teams, and providing regulatory assistance to Customer Service and other stakeholders.

Finally, you will collaborate with cross-functional teams to integrate regulatory requirements into business processes.

Key Responsibilities

• Execute regulatory classification and strategy for selected product areas.
• Represent regulatory affairs in product development projects,and work close together with our regulatory compliance department.
• Create and maintain regulatory documentation.
• Ensure alignment with the team handling product registrations.
• Provide regulatory assistance to Customer Service and other stakeholders.
• Collaborate with cross-functional teams to integrate regulatory requirements into business processes.

About You
You could come with a bachelor’s degree in Life Science, Engineering or a related field but most important is that you have at least 2-4 years of experience from a similar role within an international company. Proven knowledge and expertise in ISO 13485 and MDR 2017/745 are a requirement and experience with UDI and labeling is advantageous. You have great communication and interpersonal skills, solid organizational skills, attention to details, a positive mindset, and the ability to work effectively in a collaborative environment.

Our Culture
We offer a positive culture that prioritizes clear communication, psychological safety, and empowerment. We encourage personal development through learning programs and courses. Flexible working hours and conditions help maintain a balance between work and personal life. Our friendly and caring culture ensures that we walk the extra mile to help and support each other to grow as a team.

How to Apply
Send your application via our recruitment system by July 31st. We will go through all applications by the start of August and interviews will take place in the middle of August. For questions about the position, contact Flemming Vinding, VP of Global Quality at +45 2051 6743 or by [email protected].

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 and exploring how you can contribute to our mission of improving lives through innovative medical solutions.

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5 Jul 2024

Middelfart, DK, 5500

Interacoustics
Interacoustics 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.