Global Regulatory Affairs Manager, Medical Devices
Driven by research and a passion for science Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.
Would you like to join us in a challenging position as Global Regulatory Affairs Manager for Medical Devices? We offer an exciting job in an international company with great influence and responsibility. Your contributions will define how we work in the future.
You will be part of a Medical Device group in a newly established function, Business Support and Medical Devices. We are part of the Global Regulatory Affairs department situated in Copenhagen, and support the global regulatory functions with Intelligence, Compliance, Labeling, Certificates, Information Services and Regulatory Affairs for Medical Devices. The Medical Device group is responsible for the CE marking together with all national registrations for medical devices. Our highly dedicated and ambitious regulatory managers play a key role in developing regulatory strategies for the successful approvals of Ferring’s medicinal products, medical devices and combination products.
Reporting to the Associate Director for Medical Devices, you will be responsible for
- Supporting development and lifecycle projects for drug-device combination products and medical devices
- Creating and coordinating the submission documentation for the medical device part of drug submissions
- Reviewing technical file documentation for medical devices and advise in the creation of the technical file
- Maintaining EU and US registrations for Class I and II (a, b) medical devices
- Contributing to the change control process for Medical Devices
- Maintaining the regulatory processes within the Quality Management System
- Contributing to the Medical Device intelligence review and monitoring
You will be working in international teams to provide advice to other functions such as Pharmaceutical R&D and Pharmacovigilance regarding the regulatory requirements to medical devices.
The ideal candidate holds a Master degree in engineering, pharmacy or natural science. We expect you to have 3 or more years of experience in a regulatory position within the medical device or pharmaceutical industry.
Experience in CE marking and US submission compilation for medical devices is essential. Should you already be experienced with drug-device combination products (e.g. drug delivery products) this will be an advantage.
The right candidate has a good understanding of the Quality Management Systems according to ISO 13485 and 21 CFR 820.
You should be a person that thrives on working in an environment with a diversity of products and projects. Integrating well into a team does not keep you from working independently on an assignment. Good verbal and written communications skills in English are essential.
Further information about the position can be obtained from the Associate Director Martin Gabler via +45 28787972. Your application and CV in English should be submitted as soon as possible but no later than 28 May 2017, as we will be reviewing incoming applications on an ongoing basis.