Global Regulatory Affairs Manager - Medical Devices

Global Regulatory Affairs Manager – Medical Devices (temporary position)
Are you looking for your next challenge? Would you like to use your experience with medical device regulations and design control to provide Ferring with regulatory medical device expertise and strategy?

In this 18-month position (parental leave cover), you will support development and lifecycle projects for drug-device combination products and medical devices.
“An exciting thing about Ferring is that we’re not all working on the same big product. My team works on a broad range of medical devices – from injection pens and needles to software and pumps”, explains Martin Gabler, Associate Director for Medical Devices.

“We don’t have a set structure for everything, which means that not only do you get to use your medical device knowledge broadly in a pharma context, but your contributions will define how we work in the future,” Martin elaborates.

Ferring + you You will join our Medical Device group within Global Regulatory Affairs. We are responsible for intelligence, compliance, labeling, as well as CE marking, along with national registrations for all Ferring medical devices.

While you can rely on your immediate team for support, much of your time will be spent contributing to international teams and supporting other functions such as Global Device R&D, Global Quality Assurance, and Pharmacovigilance regarding regulatory requirements for medical devices.

Your day at Ferring As a team, we focus most of our efforts on three main areas: project support, global submissions, and compliance – and because of our specialist knowledge, we become natural go-to-people on medical device queries for colleagues across the organization.

Working independently, you will ensure the required medical device certification and provide project support to enable global submissions and approval of medicinal products. More specifically, your primary responsibilities will be to:

• Create and coordinate submission documentation for the medical device part of drug submissions
• Review technical file documentation for medical devices and advise in the creation of the technical file
• Maintain EU, US, and Canadian registration for Class I and II medical devices

You will be based alongside your team at our spectacular state-of-the-art office, Soundport, which houses our International Pharma-Science Center (IPC). However, as we collaborate internationally, you will have great flexibility in managing your workday – including working from home up to 2 days a week.

Behind our innovation – there’s you You are excited by the opportunity to apply your medical device knowledge in a pharma context and work on a diverse range of products and projects. You view our broad scope as an interesting challenge, and you are ready to apply your experience independently and act as a medical device specialist in cross-functional teams.

To do so, we are looking for you to have:

• experience with technical documentation and conformity assessment
• experience managing regulatory strategies for medical devices
• a good understanding of ISO 13485 requirements
• strong proficiency in EU MDR and US MD regulations
• excellent verbal and written communication skills in English

People come first at Ferring At Ferring, we believe in the power of people. You are not only encouraged to speak your mind; we expect you to. Making a difference in the lives of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions.

Behind our purpose – there’s you If our mission and your vision are aligned, please apply. Kindly include a few lines regarding your motivation for applying in the CV or a cover letter. Please note that we review applications continuously and close the process when we find the right match.

For any questions, please reach out to Associate Director Martin Gabler at +45 2878 7972.

If you have questions about the recruitment process, please contact Talent Acquisition Partner Mette Markussen at [email protected].

We are unable to offer relocation assistance for this position. Candidates must be located in the Oresund region or willing to relocate at their own expense.

Note to agencies: This search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us unsolicited profiles.

At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology, and urology. Ferring + You is all about working together and sharing ideas so that we can bring science to life for patients around the world. Read more at ferring.com.

Location:
Ferring Denmark