Experienced Medical reviewer on behalf of European Notified Bodies; Experienced Clinical Auditor; Experienced Auditor for Venture Capital ; Due diligence audits. Subject matter Expert in diverse clinical fields and worldwide regulatory affairs. Years of hands-on experience in the medical device industry, combined with business acumen of an executive. Unique understanding in worldwide regulatory requirements, clinical field, users and medical devices providing extremely important input to R&D group and company.My experience has allowed me to gain a valuable understanding of the Industry with creative input into Clinical, Regulatory and Business strategy. KEY SKILLS * Trainer : CER ; CER MDD vs MDR * MDR, MEDDEV 2.7/1, IEC62366-1(USABILITY) * Auditor - VCs- M&A*NB reviewer *Post Marketing and Vigilance * PMS + PMCFU*Heart valves, interventional cardiology, obstetrics, wound care, combination devices, orthopedics, Laser *Biocompatibility- Pre-clinical studies- Packaging- Sterilization*Board level experience in start-ups, in the field of medical device*Experience liaising between physicians and R&D team.•Experience in development, implementation & execution of study protocols for clinical trials in Europe, North America and Brazil•Successfully passed audits from competent authorities such as ANSM (AFSSAPS)•Experience in development of clinical trial strategies and investigation plans •Familiar with European, FDA and GCP guidelines•Experience with Regulatory fillings ( e.g CE- PMAs- 510(K)s- CFDA- KFDA)•Perfect knowledge of working according to QA requirement •Excellent team work capabilities: working with local team members or projects with team members located in different countries•Well-developed written, verbal communication and interpersonal skillsSpecialties:Preclinical activities- Strategy implementation- Clinical activities and interaction with colleague physicians. Regulatory activities. Multicultural & Multi lingual