Regulatory Compliance Specialist

Do you want to influence regulatory compliance and future medical product development in a global company that provides an attractive workplace for the industry’s best and brightest?

At Interacoustics we are committed to creating innovative solutions that improve lives. Our values shape everything we do – And with an international and open-minded approach, we promote a culture of trust, flexibility, social engagement, and personal development opportunities while leveraging the latest technology stack to ensure growth in our products and services.

The Role:

As a Regulatory Compliance Specialist at Interacoustics you will join a team of four skilled colleagues based in Middelfart and report to the Regulatory Compliance Manager. Here you will play an important role in ensuring that our products meet all regulatory requirements while upholding our commitment to quality and innovation. You will collaborate closely with cross-functional teams to navigate complex regulatory landscapes and contribute to the development of cutting-edge medical technologies that make a difference.

Regulatory intelligence and recertification:

As a member in the regulatory compliance team, you will be involved in the following:

• Regulatory surveillance
• Safety related risk analysis ensuring new standards
• Recertification is handled
• New standards implemented in our knowledge base

A significant part of your role will be to take part in planning and implementing the required documentation, including usability engineering and risk management, in compliance with current regulatory standards for medical device development.

Working side-by-side with our developers and regulatory compliance team members, you will be responsible for:

Conduct regular internal audits to assess regulatory compliance with applicable legislations and regulations You will develop and implement policies and procedures to ensure compliance with industry standards.

Stay informed about changes in relevant laws and regulations and communicate updates to the team. Respond to compliance inquiries and provide guidance to internal stakeholders and assist in the development of training programs to educate employees on compliance-related matters.

Your interpersonal skills are just as important as your professional skills.

This means you have good communication skills and the ability to collaborate effectively with cross-functional teams. You have a great attention to details and with your analytical skills, the ability to interpret and apply complex regulatory requirements. You have experience from working in a larger organization under a quality management system with a set framework and procedures.

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, and we expect you to start the 1st of August 2024. Applications are evaluated continuously.

For questions regarding the position, please contact Anders Damkjær Bæk, Regulatory Compliance Manager, Global Quality, Diagnostics, at +45 28 59 21 66. For questions regarding the recruitment process or our company, please contact Debbie Nielsen, HR Specialist at dbni@interacoustics.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.