MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure. They represent Diagnostics and Medical Devices manufacturers operating in Europe.
MedTech Europe is currently looking for a Regulations and Industrial Policy Manager Specialist in Medical Devices Regulation for 1000 Brussels
Your Role in the Association
Reporting to Director Regulations and Industrial Policy
As a member of the Regulations and Industrial Policy team, you will be involved in achieving MedTech Europe's goals in a broad range of regulatory issues with a specific focus on the EU Medical Devices Regulation 2017/745.
In this role, you will help to interpret and advise on this EU Regulation, and on related industrial policy matters, such as standardisation. Together with, and in support to, the Senior Regulatory Adviser, you will coordinate several committees that work on implementing various aspects of this regulation, including the chapters on clinical evidence and post-market surveillance etc.
In collaboration with the Director Regulations and Industrial Policy, you will maintain and develop partnerships with stakeholders in the EU, and regularly present and represent MedTech Europe member's interests and initiatives at the level of the EU institutions and agencies.
By excelling in this role over the course of 3-5 years, you will have the opportunity to develop substantially in knowledge and responsibility, eventually becoming a lead authority within the association with respect to Regulation 2017/745.
Strategies & tactics
- Together with the Senior Regulatory Adviser and the Director Regulations and Industrial Policy, develop and implement strategies to collect the members' interests and advise on successful strategies to ensure regulatory approaches that support their interests.
Technical, scientific & regulatory affairs expertise
- Ensure that the regulatory and industrial policy affairs activities are in line with the association's policies, procedures and practices.
- Provide regulatory and scientific advice to team and members on the EU Medical Devices Regulation 2017/745 and on the potential legal and practical impact of legislation on the members.
- Collect input from members and feed industry comments into responses to public consultations in the relevant policy domain.
- Suggest opportunities for new work items, advocacy and communication.
- Lead internal members groups to meet the objectives including coordination of the debate, building consensus and advise on possible successful regulatory strategies.
- Develop position papers and presentations to support projects and programmes.
- Represent MedTech Europe and MedTech's positions to external stakeholders including the EU, third country and international institutions.
- Foster and maintain key contacts with key stakeholders, in particular within the EU institutions.
- Alert MedTech hierarchy and members to issues ahead of time.
- Updating the MedTech website with information relevant to the Regulatory Affairs activities and to assigned task forces/working groups.
- Response to members' and non-members requests.
- Communicate information on meetings, projects and programmes to MedTech members and externally to identified stakeholders.
- Promote new topics and innovative approaches/solutions.
- Master's Degree, preferably in Medical, Legal, Natural or Political Sciences
- 2 to 4 years' experience in EU affairs and/or healthcare: government, industry or civil society (e.g., NGO or patient advocacy)
- Good level of regulatory or scientific knowledge related to healthcare, preferably in relation to medical technology
- Good scientific, medical, or bio-engineering knowledge
- Experience in leading or working in projects
- Experience of or within the EU institutions a plus
- Fluent in English, Other EU language(s) highly appreciated
- Ability to easily engage peers, external groups and international bodies and create own network
- Eloquent communication skills (written and spoken)
- Proactive team player, committed to excellence
- Working knowledge of Microsoft Windows (Word, Excel, PowerPoint, Outlook)
Competitive Salary, Performance Bonus, Luncheon Vouchers, iPhone + Subscription, Laptop, Pension Plan, Full Medical Plan (+Family) and Transport Reimbursement
For more information: Call EMMA WAITES on the number: 02 738 02 63 GSM 0475 614967