Clinical and Regulatory Affairs Manager

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

At SGS Belgium NV, Certification and Business Enhancement we have an excellent opportunity for a Clinical and Regulatory Affairs Manager to join the Belgian NoBo Medical Devices team.

The successful candidate will manage and have oversight of clinical evaluation assessments under 93/43/EEC

Job description:

  • To act as the primary clinical expertise within medical device conformity assessment activities, and to participate in the representation of SGS clinical activities to competent authorities

  • Oversight of clinical evaluation assessments of medical devices

  • To act as product specialist for novel technologies, implants and clinical evaluations to ensure understanding and compliance throughout SGS and to build up the reputation of SGS

  • To provide expert clinical advice to support all stages of the conformity assessment activities

  • To interface with client clinical experts and clinical affairs directors

  • Manage the SGS EC Design Examinations process and ensure all reviews under 93/42/EEC are technically sound and are delivered to a high service standard

  • Participate in the management of medical devices certification with particular emphasis on pre clinical and clinical issues, EC Design Examinations and technical file reviews under 93/42/EEC

  • Ensure the highest level of service is provided to global customers through efficient service delivery and adherence to SGS procedures and processes and to promote SGS as the preferred supplier of EC Design Examinations

  • To develop, update and maintain appropriate training packages (wiith focus on the clinical evaluation) for clinical experts and external clinical specialists

  • When necessary to undertake chargeable review of clinical data (literature and clinical investigations)

Profile

  • Physician (essential)

  • 4 years full time work experience in the clinical evaluations, clinical trials and / or clinical data manipulation / evaluation (essential)

  • Detailed understanding of the relevant medical device regulations, normative and guidance documents i.e. EC Directives, MedDev’s, GHTF, …. (essential)

  • Effective interpersonal skills and team working ability (essebtial)

  • Experience with recognised (harmonized) standards in the field of clinical trials, compatibility and / or toxicology

  • Computer literate and experienced in use of MS Office and other software applications (desirable)

  • Experienced in reviewing clinical data files of medical devices (desirable)

  • Toxicologist, general practitioner or medical consultant (desirable)

 If you are interested in this position, please apply with your resume and motivation letter to pascal [dot] plessers [at] sgs [dot] com