Global Regulatory Affairs Manager Medical Devices

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Freedom, Indiana

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Tue, 06 Apr 2021 23:59:59 GMT

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Job Title: Global Regulatory Affairs Manager – Medical Devices Job Description: 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. We are expanding our pipeline and are therefore looking for a new colleague to support development projects and maintenance of Medical Devices. The job Reporting to the Associate Director for Medical Devices, you will be our 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. Moreover, 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, 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 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. Qualifications 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 has a good understanding of the Quality Management Systems according to ISO 13485 and 21 CFR 820. You are a person that thrives on working in an environment with a diversity of products and projects. You integrate well into a team but at the same time it does not keep you from working independently on an assignment. Good verbal and written communications skills in English are essential. Your new team You will be part of our Medical Device group in the Global Regulatory Affairs department situated in Copenhagen, with teams located in Denmark, Israel and Switzerland. 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. We work in global projects teams and across regions. Our highly dedicated and ambitious regulatory managers play a key role in developing regulatory strategies for the successful approvals of Ferrings medicinal products, Medical Devices and Combination Products. Your new workplace is first at the Ferring International Pharma-Science Center (IPC) in restad, Copenhagen. However, later in 2021 we will move to our spectacular and state-of-the-art new domicile, a future landmark located next to Den Bl Planet, near Copenhagen Airport. Contact and application Please send your application and CV no later than 31 March 2021. If you have any questions, you are very welcome to contact Associate Director Martin Gabler at +45 2878 7972. Please note that we review applications on an on-going basis and close the process when we find the right match. Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen we are nearly 600 people, primarily scientists and specialists working to break new land to help people live better lives. We focus our R & D efforts on peptide-based drugs and biotechnology derived medicines. As a privately-owned company we 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 our ambition of becoming the worlds 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 us. Read more at Location: Ferring Denmark