Medtronic (Senior) Regulatory Affairs Specalist in Maastricht, Netherlands
(Senior) Regulatory Affairs Specalist
Maastricht, Limburg, Netherlands
Jul 09, 2017
For our Bakken Research Center in Maastricht, the Netherlands.
The Regulatory Affairs department within the Bakken Research Center in Maastricht, the Netherlands supports the Europe and Middle East Africa (EMEA) region, but has a strong focus on Europe due to the strict regulations in the EU. The (Sr.) Regulatory Affairs Specialist works as a consultant and technical/clinical expert to the business unit and clinical departments for planning and execution of tactical and strategic regulatory programs, assessing regulatory risks, developing and implementing guidance programs in response to identified regulatory needs.
We offer you a position in which you manage regulatory submissions for new products, product changes, drug consultation dossiers for combination products, and/or clinical studies as required to ensure timely approvals for market release and commencing clinical studies. This includes, but is not limited to, reviewing submission deliverables such as labeling, technical and clinical documentation, and discussing regulatory submissions with Notified Bodies and Competent Authorities. You prepare or provide input on regulatory strategies for new products, therapies, drug consultations, and/or clinical studies, and may be consulted by the business unit or clinical departments for regulatory issues. You provide support for market-released products as necessary. This includes review of labeling, promotional material, and product/manufacturing process changes. You monitor and report changes in the regulatory environment that impact our business and alert and advice management and implement practical guidance for the enterprise to minimize the regulatory risk.
Masters degree in Engineering or Physical/Biological/Pharma Sciences
3-5 years regulatory experience in medical device or pharma industry
Experience in product development, medical writing , and/or clinical trials
Fluent in English
Medtronic offers you a professional, international, dynamic and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your Development Plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization.Is this the position you were waiting for? Then please apply directly via the apply button!
As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year.We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today. But no one can do it alone. That’s why we’re committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.
Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 85,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Medtronic Eindhoven Design Center and Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,500 employees.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together .