Dirk Steenmans

Dirk Steenmans

Director, International Regulatory and Clinical Affairs
Background

Mr. Steenmans is a biologist with 14 years international regulatory and clinical compliance experience in medical device sector.

 He is an expert in RA and CA strategy development and integration of clinical data into technical documentation.

He specialized in cardiological and neurological technologies which over 6 years at BSI including, notified body operations, client management, conformity assessment, audit and training.

Mr. Steenmans has thorough knowledge of developing and refining medical device regulatory and clinical compliance strategies and submission for neuromodulation/stimulation, combined devices and organ replacement devices like cochlear implants, neurostimulators, stents, VADs, brachytherapy and AIMD drug device combinations.

Education

Mr. Steenmans is proficient in 6 languages (Dutch, French, Spanish, Italian, English and German), has a degree in Music, a Master of Science in Biology form the VUB, an EU joint Master of Science in Natural Resource Management form the UIB, specializing in mathematical modeling and completed the Strategic Management Program at Harvard University.

Experience

During his time at implant manufacturer Advanced Bionics, a SONOVA company, Mr. Steenmans held various leadership positions and gained broad specialist and management skills: He was Director Regulatory and Clinical Affairs for APAC and EMEA, managing teams in Tokyo, Beijing, Zurich and Los Angeles. Prior to this position he founded a consultancy firm and acquired experience in product and business development as well as the operations of clinical and regulatory affairs mandates. In his most recent position as technical reviewer and scheme manager in the BSI AIMD team, the EU Notified Body, he assessed multiple initial applications and change driven dossiers, maintained clients’ certification status and performed unannounced audits.

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