Job Description :
To succeed in this role, you should have the following skills and experience
Bachelor’s degree and a minimum of 7 years of related CSV experience in the medical device or other FDA/ISO regulated industry
Working knowledge of 21 CFR Part 11 and GAMP 5 is a must
Understanding of appropriate global medical device regulations, requirements and standards, including of the following is a plus: FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, ISO 14155, and ICH E6.
Government/regulatory-body Quality System auditing/inspection experience (i.e., former FDA preferred)
Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating ?exibility in prioritizing and completing tasks and communicating potential con?icts to a supervisor
Attention to detail, organized and self-driven
Solid interpersonal and communication skills
Ability to communicate effectively both orally and in writing; smart technical writing skills a must
Effective time management; able to balance multiple projects simultaneously
Open to other’s ideas and working collaboratively across functions and/or businesses throughout all levels of the organization