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Global Regulatory Affairs Manager, Medical Devices

Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology.

At Ferring International Pharma Science Center (IPC) in Copenhagen they are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. Ferring focus their R&D efforts on peptide-based drugs and biotechnology derived medicines.

As a privately-owned company, Ferring benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling Ferring’s ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of the employees. Read more at ferring.com

Your new workplace is first in Ørestad, Copenhagen. However, later in 2021 Ferring will move to their spectacular and state-of-the-art new domicile, a future landmark located next to “Den Blå Planet”, near Copenhagen Airport.

The Department

You will be part of the Medical Device group in the Global Regulatory Affairs department situated in Copenhagen, with teams located in Denmark, Israel and Switzerland. The team supports all global projects up to the approval of the product in the US, EU, Canada, and Japan. The Medical Device group is responsible for Intelligence, Compliance, Labeling, Certificates in relation to Regulatory Affairs, as well as the CE marking together with all national registrations for Medical Devices. They work in global project teams and across regions.

All the 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.

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 & dedicated

– Worldwide company with innovative treatments
– You will be working with regulatory strategies for medical devices and combination products
– You have influence and work with a broad 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.

Reporting to the Associate Director for Medical Devices, you will be the new Global Regulatory Affairs project team member providing regulatory Medical Device expertise and strategy. You ensure the required Medical Device certification and project support enabling global submissions and approval of medicinal products. You will work closely with the Global RA Product Manager in the Global Regulatory Project Team and the subsequent Medical Device and drug product teams.

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, US, and Canadian registrations for Class I and II Medical Devices
– Coordinating the labelling process for Medical Devices
– Implementing the new Medical Device Regulation
– 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 different highly skilled international teams to provide advice to other functions such as Pharmaceutical R&D, Global Quality Assurance and Pharmacovigilance regarding the regulatory requirements for Medical Devices.

Your Talent

The ideal candidate holds a degree in Engineering, Pharmacy or Natural Science. We expect you to have 5 or more years of experience in a global regulatory position within the Medical Device or Pharmaceutical industry. The seniority will be assessed based on your qualifications.

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) and regulatory affairs of medicinal 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 thrive on working in an environment with a diversity of products and projects. You integrate well 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 “1730/GRA Manager” by way of e-mail to job@besttalent.dk  You can read more about Best Talent at www.besttalent.dk.