In Vitro Diagnostic Medical Devices Manager

Company

Why work for MedTech Europe?

Are youpassionate about healthcare and innovative medical testing technologies?

In that case MedTech Europe, has the ideal job for you.

You will contribute (under the strategic direction of the Director IVDR/MDR, Petra Zoellner) to MedTech Europe’swork for the implementation of the In VitroDiagnosticMedical Devices Regulation (EU) 2017/746.

This is a role with a strong regulatory focuswhere you will interface with members, the European Commission and national regulatory authorities.

You need to follow technical dossiers thoroughly in order toachieve concrete outcomes, communicate and explain complex issuesto different audiences, build consensus with members and contribute to the successful outcome of projects.

Function

Your key responsibilities

• Contribute to implementing IVD Regulation (EU) 2017/746, with experts and colleagues
• Drive working groups and projects and work closely with the Medical Devices team
• Coordinate committee and working groups made up of member representatives
• Represent the IVD manufacturing sector in European Commission regulatory expert groups and other fora
• Develop or coordinate industry guidanceon topics related to the implementation of the IVD Regulation
• Develop or coordinate MedTech Europe responses to public consultations, position papers and presentations as identified by the working groups

Profile

The ideal candidate

• Has minimum 3 years of experiencein EU related regulatory policy OR in the in vitro diagnostic medical devices industry.
• Holds a university degree or other relevant qualifications in Policy and Political Science, European Studies, Law, Laboratory Medicine, or other relevant scientific discipline
• Is fluent in both written and spokenEnglish
• Has an excellent command ofMS Word, Excel, PowerPoint and Outlook
• Has an interest in shaping healthcare policy with a strong regulatory focus
• Has a good understanding of EU policies and the functioning of the EU (a must)
• Is a persuasive communicatorin an international environment to both internal and external audiences
• Is well-organized, well able to meet deadlines whilst always striving for operational excellence
• Is analyticalwith the proven ability to rendercomplex legal and technical matterssimple
• Is a motivated team player who can work proactively and independently

Offer

• You will not only have the opportunity to be a member of a motivated, dynamic, and international team(regular team events), but also have:
• Competitive Salary + Performance Bonus
• Net Teleworking Allowance, Lunch Vouchers
• PensionPlan,MedicalPlan (+ Family)
• Mobile Phone Subscription, Laptopand TransportReimbursement
• 2 DaysTeleworking per week
• Possibility to telework from abroad up to 25% of the year
• 26 Days of Holiday
• Be a representative of a well-established and innovative European industry
• Internal network of members, experts and coaches who can bring knowledge and experience in managing different challenges and objectives.
• Continually learn and develop expertise in medical devices regulations especially IVD regulatory affairs.
• Opportunity of other trainings and personal development.

Hiring Process

• Istinterview with Petra Zoellner, IVDR/MDR Director
• 2nd interview with the MedTech Europe’s Medical Devices team
• 3rdinterview with Patricia De Buyl, Human Resources Senior Manager
• Decisionafter maximum 2 weeks

We are looking forward to receiving your CV

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