Current Openings

You will contribute (under the strategic direction of the Director IVDR/MDR, Petra Zoellner) to MedTech Europe’s work for the 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, the European Commission and national regulatory authorities.

You need to follow technical dossiers thoroughly in order to achieve concrete outcomes, communicate and explain complex issues to 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 guidance on 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 experience in 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 spoken English
• Has an excellent command of MS 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 communicator in an international environment to both internal and external audiences
• Is well-organized, 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 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
• Pension Plan, Medical Plan (+ Family)
• Mobile Phone Subscription, Laptop and Transport Reimbursement
• 2 Days Teleworking per week
• Possibility to telework from abroad up to 25% of the year
• 25 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

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

We are looking forward to receiving your CV

Please upload your CV via this link (you will be redirected to the Profile Group website).

As part of MedTech Europe’s External Affairs team, the Communications Intern is responsible in supporting different projects aligned with MedTech Europe’s communications, social media and media strategy.

Specific Responsibilities

MedTech Europe internal & external newsletters:

• Compile and edit content for newsletters
• Support the set-up and the dissemination of regular newsletters
• Manage lists of newsletter subscribers and ensure regular updates

Online platforms and social media:

• Upload and manage content on MedTech Europe online platforms (website and social media)
• Source and create content for MedTech Europe’s social media channels
• Social media monitoring & reporting

Media monitoring :

• Monitor daily media alerts
• Daily dissemination of news to relevant colleagues

Communications support on MedTech Europe activities:

• Support team in communication objectives and projects
• Ensure all databases and documents are up to date at all times
• Provide further assistance as required

Must-have skills

• Proven excellent writing skills for online as well as offline content
• Excellent knowledge of spoken and written English
• Digital savvy (including social media)
• Proven ability to formulate and articulate clear messages about complex subjects
• Knowledge of communications strategy development and execution processes
• Reactiveness and proven experience in taking responsibility
• Meticulous/eye for detail
• Enthusiastic

Nice-to-have skills

• Familiarity with the EU healthcare landscape
• Fluency in other EU languages
• Presentation skills
• Graphic design skills

Internship Details

• Duration: 1-year full time (39 hours a week)
• Early application is encouraged as applicants will be assessed on a rolling basis
• Starting date: April 2022 (negotiable)
• Remuneration: Convention d’immersion professionnelle (CIP); only applicable if the candidate holds a diploma and is not linked to any internship with the university.

How to apply

Please send your CV and Cover Letter, showing why you would make an excellent candidate for the position and your interest in the medical technologies industry, to Domenico Iannone, Officer Communications: [email protected].

MedTech Europe is an equal opportunity employer.

Reports to

MedTech Europe Compliance Panel

Background

In the field of healthcare compliance, MedTech Europe’s and EFPIA’s Member companies have recognised the need for and value of guarding and promoting their reputation for integrity and responsibility as stakeholders become less tolerant of lapses. A focus of attention are the interactions with Healthcare Professionals (HCPs). MedTech Europe and EFPIA support their respective Members by providing guidance on how to conduct their business responsibly.

Following their respectives codes of ethical practice, MedTech Europe’s and EFPIA’s corporate Members may sponsor third-party educational conferences, such as medical congresses, symposia, seminars, training courses and therapy-orientated training, in order to promote scientific knowledge, medical advancement and assist in the delivery of effective healthcare by healthcare professionals (e.g. physicians, nurses). However, companies have to make sure of the bona fide nature of educational and scientific activities, in order to avoid sponsorships which could be construed as inappropriate value transfer and illegal financial ties between industry and clinicians.

In collaboration with MedTech Europe, EFPIA and the MedTech Europe’s Compliance Panel, the Compliance Officer will manage a system to support the respective Members of MedTech Europe and EFPIA to assess industry’s sponsorships of educational activities in conformity with the relevant Code.

Main Responsibilities

The Compliance Officer shall be responsible for the following tasks:

• Manage the MedTech Europe Conference Vetting System and the EFPIA e-4-ethics system to ensure that conferences subject to assessments meet the MedTech Europe’s and EFPIA’s ethical standards, included in the MedTech Europe Code of Ethical Practice and the EFPIA Healthcare Professionals Code;
• Serve as the key contact point between the MedTech Europe Secretariat, the MedTech Europe Compliance Panel and where necessary the EFPIA and MedTech Europe Members, Healthcare Organisations (HCOs), Professional Congress Organisers (PCOs), and where relevant sister organisations in order to facilitate the acceptance and understanding of the EFPIA e-4-ethics and the MedTech Europe Conference Vetting System;
• Serve as the point of contact for handling all vetting assessment submissions made under the MedTech Europe Conference Vetting System and EFPIA’s e4ethics;
• Escalate submissions to the MedTech Europe Compliance Panel for advice and/or decision as deemed necessary;
• Be responsible for all tasks associated with running of the Conference Vetting System and e4ethics including but not limited to software update, online data entry, quality control and communication with all stakeholders as well as the ethical logo;
• Maintain integrity and documentation of the two systems through active management of all records.

The foregoing list is subject to reasonable modification and/or additions from time to time.

Skills and competences

Requirements and Qualifications

• Willing to work as an independent contractor;
• Bachelor’s degree or its equivalent;
• At least 5 years of relevant professional experience, preferentially in compliance or related areas;
• Good oral communication and ability to present succinctly;
• Full professional proficiency or native-level English, both oral and written, and at least one other European language;
• Ability to work as a team to complete a project in a timely manner;
• Ability to implement a repeatable process methodology and to define a systematic approach to delivering solutions and achieving Associations’ objectives;
• Proficient with, or able to quickly become proficient with, a range of general and specialized IT applications and software, used in the association;
• Collect, analyze, and summarize information and trends as needed to prepare project status reports;
• Proactive, flexible, open minded and reliable with high level interpersonal, organisational and management skills;
• Excellent analytical skills;
• Strong interest in compliance-related matters and values.

Other

• Candidates must be eligible to work in Europe and preferrably live in Belgium. Non-EU candidates are encouraged to apply and to verify the non-existence of obstacles for their employment, entrance and establishment in Belgium.

Application Instructions

Interested candidates should send a CV in English and a motivation letter to Aline Lautenberg ([email protected]) with the Subject: CVS2023 Application – Compliance Officer.

Deadline of submission: 15 March 2023.