Global Market Access Regulatory Specialist

1 month ago

Ballerup, Denmark Gn Hearing AS Full time

Global Market Access Regulatory Specialist

Introduction to the Position

Join GN Hearing's Market Access team, which is part of the Corporate Quality department, as our new Global Market Access Regulatory Specialist, where your contributions will play a vital role in securing worldwide Medical Device product registration approvals. You will become a vital link between our development programs and our markets, ensuring product approvals with focus on time to market.

The Team You Will Be Part Of

Our team is responsible for worldwide Medical Device product registrations in close co-operation with relevant global and local stakeholders. We collaborate with a diverse range of stakeholders, from subsidiaries, distributors, product management and R&D teams. As part of our team, you'll find a supportive environment that values a good working environment, teamwork and the contribution of every team member.

Your contribution is appreciated, and you will:

Develop, maintain, and execute on Global Market Access Plans.

Co-ordinate and communicate technical file submissions.

Secure Product Approvals from relevant country official Authorities in close co-operation with colleagues worldwide.

Continuously assess and monitor medical device requirements, ensuring a successful product registration process and approval.

Engage with colleagues cross functional in the organization and third-party test houses to gather product documentation and evidence.

Support, align and communicate with country managers about market access processes, registration cases and plans.

Become a Market Access country SME for specific markets.

Contribute to Market Access processes and templates.

Provide Market Access support to inspections and audits.

To Succeed in the Role, We Imagine That You:

Have great collaboration and communication skills and you thrive in working in an international environment with colleagues worldwide.

Have attention to details, deadlines & solutions.

Have experience with Market Access, medical device registration and project management.

Have knowledge of EU MDR, ISO 13485 and other medical device standards and regulations

Have experience with medical device submissions to authorities.

Communicate fluently in English, both verbally and in writing.

We encourage you to apply

Even if you don’t match all the above-mentioned skills, we gladly receive your application if you think you have transferrable skills. We highly value the right mindset; motivation and energy and we believe that the right personal competencies are highly important for creating success.

We are dedicated to an inclusive recruitment process and all applicants will receive equal consideration for employment.

How to Apply?

Ready to make a difference? Apply latest by April 30th 2024, using the ‘APPLY’ link, submitting your CV and application. We are reviewing applications on a rolling basis, so early submission is encouraged. For inquiries on the position, please contact Pernille Bartel, Head of Market Access at

We hope you will join us on this journey and look forward to receiving your application.

#LI-Resound

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