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Global Regulatory Affairs Manager, Medical Devices

The Company

Ferring International PharmaScience Center, 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, Ferring Pharmaceuticals develop medicine on the body's own terms. Ferring Pharmaceuticals believes in the power of people and research - and goes where ideas and research takes us. To sustain the effort of developing new medicine, Ferring Pharmaceuticals rewards talent with influence. In return, employees are expected to be ambitious and innovative. See more at www.ferring.com

The Department

The Development Projects team is part of the Global Regulatory Affairs department situated in Copenhagen. The team supports all global projects up to the approval of the product in the US, EU and Japan. 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.

The Medical Device group is responsible for the CE marking together with all national registrations for medical devices.

Would you like to join Ferring in a challenging position as Global Regulatory Affairs Manager for Medical Devices? They offer an exciting job in an international company with great influence and responsibility. Your contributions will define how you are going to work in the future.

Global Regulatory Affairs Manager, Medical Devices
Skilled & highly dedicated

  • Worldwide company with innovative treatments
  • You will be working with regulatory strategies for medical devices
  • You have influence and work with a diversity of products and projects

The Challenge

You can expect to be working according to highest standards of current practice in order to fulfill the company’s needs for data acceptable worldwide.
Your main responsibilities cover:

  • 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

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. You will be reporting to the Associate Director for Medical Devices

Your Talent

The ideal candidate holds a 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 also has a good understanding of the Quality Management Systems according to ISO 13485 and 21 CFR 820.

As a person, you should thrive on working in an environment with a diversity of products and projects. You like being integrated into a team as well as working independently on an assignment.

The successful candidate has high quality standards and is committed to meet deadlines. In addition, you are well organized, pro-active, flexible and have the ability to work on multiple tasks.

Excellent knowledge of MS Office and fluency in English with good verbal and written communication skills is a given.

Application

Best Talent is responsible for the recruitment for this position at Ferring and review your application on a confidential basis. Forward your application including your CV attention 1545 “GRA Manager” by way of e-mail to job@besttalent.dk or to Best Talent, Rungstedvej 41, DK-2970 Hørsholm.

You can read more about Best Talent at www.besttalent.dk.

Apply online Gem job

Arbejdssted

Copenhagen

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