Regulatory Affairs Specialist

Job description

For our Bakken Research Center in Maastricht, the Netherlands.

YOUR CHALLENGE
The Regulatory Affairs department within the Bakken Research Center in Maastricht, the Netherlands supports the regulatory activities in the EMEA region (Europe, Middle East and Africa) with a strong focus on Europe due to the strict regulations in the EU. The Regulatory Affairs Specialist works as a geography consultant and technical regulatory expert for planning and execution of tactical and strategic regulatory programs, assessing regulatory risks, developing and implementing guidance programs in response to identified regulatory needs

OUR OFFER
We offer you a regional regulatory affairs position with a focal point to support and coordinate the regulatory activities and products submissions in MEACAT (Middle-East, Africa, Central Asia and Turkey), and Eastern Europe (EE) countries.

You assists the direct manager to coordinate and implement country specifics regulatory projects effectively. You work in close collaboration with the Regulatory and Quality teams as well as the Medtronic Strategic Business Units (SBUs) to solve complex regulatory issues for the region.

You ensure that prepared documentation meet external and internal requirements as required by Competent Authorities (CAs) (i.e. submissions for new products, renewals of country approval licenses, Tenders, and product change notifications), to ensure timely product approvals for market release ).

You provide support for market-released products as necessary, which include product/manufacturing process changes, new product launches and coordination with Supply Chain, Customer Service and Regulatory Operations.

You monitor and report changes in the regulatory environment (i.e. new medical device regulations) that impact our business, alert and advice management, and implement practical guidance for the enterprise to minimize the regulatory risk. You provide input for regulatory strategies for new therapies and may be consulted by the business units for various regulatory issues in the region.

You develop proficiency in the applicable regulatory requirements and interface with the appropriate Medtronic representatives, communicate any issues to the business units and upper management, as well as other regulatory and operations stakeholders, and ensure to organize country specific meetings whenever needed to respond to MoH requests in a timely manner.

You prepare position papers on interpretation in order to get a harmonized approach within the region for the whole enterprise.

You also provide regulatory support to the business units and local Regulatory Affairs team during facility inspections by MEACAT-EE regulators and actively participates in the transposition of international standards into Medtronic corporate or RA policies and procedures.

You lead all the strategic regional monthly meetings between the in-country regulatory and quality teams, the SBUs and local or regional management teams. You also carry out independently complex regulatory affairs administrative duties and regulatory databases.

You have the ability to act with team spirit and to work on multi-projects environments, and can easily redefine the priorities.
YOUR CAREER

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!

ABOUT MEDTRONIC
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 .

Desired profile

YOUR PROFILE
·  Bsc or Msc degree preferably in Medical or Technical areas
·  3-5 years regulatory experience inmedical device industry
·  Professional background within Regulatory Affairs for Emerging Markets is a strong assetPlanning and organizational skills, customer focused and strong attention to details and quality in all reporting materials
·  Ability to communicate effectively
·  Profiency in English, both written and spoken, other languages are a plus
·  General business and presentation skills
·  Strong Team player
·  Computer skills (MS Office)