Regulatory Affairs Manager EDMA

European Diagnostic Manufacturers Association

Brussels, Belgium

The ideal candidate has strong interpersonal and intercultural skills. Within our dynamic nine person EDMA team, he will become an expert in IVD Regulatory issues which will include:

• Building up a consensus on regulatory issues relevant to the IVD industry, by providing a framework for exchanging information, and stimulating discussions and debate;
• Provide a contact point for EDMA members for regulatory issues;
• Prepare and/or deliver presentations on EDMA activities;
• Attend external meetings and conferences as needed and report back on the discussions pertinent to EDMA members;
• Assist in the organization of meetings, coordinating debate, recording discussions and developing written input as necessary;
• Play a role in the publishing of information for members.

Qualifications and competence:

• At least five years of professional experience with regulatory or policy making at the EU level (working knowledge of the healthcare sector, environmental regulations or standardisation appreciated);
• University degree or equivalent qualification;
• Excellent verbal and written communication skills in English. Additional languages are an asset;
• Proven ability to understand and summarise complex technical/regulatory issues;
• Ability to gather information necessary to achieve objectives, using a variety of sources;
• Capacity to easily establish and develop effective professional relationships.

It is expected that the candidate will, after training, be able to work autonomously on selected topics. He/She will work closely with the other Regulatory associates as well as with the Communication department. Remuneration will be in accordance with experience and abilities.

Applications and CV to: human.resources@edma-ivd.be before 8 September 2011

EDMA, the European Diagnostic Manufacturers Association, represents national associations and major companies engaged in the research, development, manufacture or distribution of In Vitro Diagnostic (IVD) tests in Europe. Through its membership, EDMA represents in total more than 500 companies (or over 700 legal entities) across Europe. The mission of EDMA is to raise awareness of the importance, usefulness and added value that diagnostic information can provide to healthcare. For this purpose, EDMA cooperates with European institutions, patients groups, trade associations, health professionals and academia to support an appropriate regulatory system, to work towards a realistic economic environment for healthcare in Europe and to be an effective voice in globalisation.