| Medical Device Quality Assurance Specialist at Allendale, New Jersey, USA |
| Email: [email protected] |
| From: Roshani, Vyze Inc [email protected] Reply to: [email protected] Title: Medical Device Quality Assurance Specialist Location: Allendale ,NJ(Remote) MOI: Skype Must have: Orthopedic Experience EU MDR Expertise 2-10 years experience- PhD level coming from a Research Background who would write the Strategy for the EU MDR Clinical Evaluation Report which will include a set of robust, objective and scientific analysis of clinical evidence. Review and evaluate orthopedic implantable medical device files to ensure compliance with applicable post market surveillance regulations and standards Research, monitor, and investigate customer complaints and ensure they are addressed in a timely manner Identify and assess potential safety risks associated with orthopedic implantable medical devices Provide guidance and direction to other team members on post market surveillance related matters ensuring that team members understand the applicable regulations and standards These individuals must have a degree in a scientific or engineering field, with 2-10 years of experience in post market surveillance in the orthopedic medical device industry. PhD. preferred. Presently all existing team members have a PhD. and have come from a Research background. Be a highly organized self-starter with strong knowledge of the EU MDR as well as the FDA medical device regulations Possess excellent communication and problem-solving skills, as well as an understanding of the global regulatory environment and knowledge of risk management principles Regards Roshani [email protected] Keywords: New Jersey Medical Device Quality Assurance Specialist [email protected] |
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| Fri Mar 29 13:18:00 UTC 2024 |