In Vitro Diagnostic Medical Devices Senior Manager
il y a 1 semaine
Company details
Are you passionate about healthcare and medical testing technologies?
Do you want to play a role in shaping policies to promote innovation for the growing healthcare needs?
Do you have around 8 years of solid working experience in association management and EU related regulatory policy (preferably healthcare-related) or other relevant experience such as in the industry?
In that case MedTech Europe, the European Trade Association representing the medical technologies' industries, has the ideal job for you.
You will be responsible (under the strategic direction of the Director IVDR/MDR, Petra Zoellner) for leading the association's work in implementation of the _In Vitro _Diagnostic Medical Devices Regulation (EU) 2017/746.
This is a role with a strong regulatory focus where you will interface with members and with the European Commission and national regulatory authorities.
You will work closely with your counterpart for medical devices and manage a team of two colleagues.Strong skills are needed to develop strategic direction (together with your member company leads), follow technical dossiers through to achieve concrete outcomes, communicate and explain complex issues to different audiences, build consensus with members and manage projects as well as team members.
Desired starting date:
As soon as possible
Function
- Act as the overall lead for the implementation of the IVD Regulation (EU) 2017/746, supporting MedTech Europe members
- Lead a highly motivated and effective IVD team to drive working groups and projects relevant to implementation of the IVD Regulation, working in close collaboration with the Medical Devices team
- Coordinate (together with the team) specific committee and working groups made up of member representatives which work on implementation of the IVD Regulation and other areas
- Represent the IVD manufacturing sector in European Commission regulatory expert groups and other fora
- Build an effective network with other EU stakeholders (e.g., with laboratories, physicians, blood banks, etc.) in the IVD medical testing space
- Develop or coordinate industry guidance on various topics related to the implementation of the IVD Regulation and Medical Devices Regulation
- Develop or coordinate MedTech Europe responses to public consultations, position papers and presentations as identified by the working groups
Profile
- Has minimum 8 years of experience in association management and EU related regulatory policy OR in the In Vitro Diagnostic Medical Devices industry.
- Experience in the medical technology industry (technical or regulatory position), for instance having worked for a Notified Body, laboratory, medical device manufacturer, EU institution or healthcare sector, is considered a plus
- 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 spoken English
- Has an excellent command of MS Word, Excel, PowerPoint and Outlook
- Has a genuine passion for shaping healthcare policy with a strong regulatory focus
- Has a strong understanding of EU policies and the functioning of the EU (a must)
- Is a persuasive communicator in an international environment to both internal and external audiences
- Is wellorganized, well able to meet deadlines whilst always striving for operational excellence
- Is analytical with the proven ability to render complex legal and technical matters simple
- Is an experienced and motivated team leader and 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
- Pension Plan, Medical Plan (+ Family)
- Mobile Phone Subscription, Laptop and Transport Reimbursement
- 26 Days of Holiday
- Be a representative of a wellestablished 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
- Ist interview with Petra Zoellner, IVDR/MDR Director
- 2nd interview with the team
- 3rd interview with Human Resources
- Decision after maximum 2 weeks
**Do not forget to mention that you found this job ad on the EURACTIV Jobsite
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