Clinical and Regulatory Affairs Manager - Belgium
- Our company is the global leader and innovator in inspection, verification, testing and certification services.
- Founded in 1878,our company is recognized as the global benchmark in quality and integrity.
- Trusted all over the world, our company 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.
Clinical and Regulatory Affairs Manager
- To act as the primary clinical expertise within medical device conformity assessment activities, and to participate in the representation of company 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 company and to build up the reputation of company
- 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 company 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 company procedures and processes and to promote company 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)
- 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)