Mick Davis Email & Phone Number

Senior Regulatory Affairs and Quality Assurance professional with a unique skill set developed over 20 years of diversified work experience with small, medium and large organizations in the patient monitoring/analytics, orthopedic, dental, biologic/tissue banking and agricultural/food processing industries.Engaging, collaborative leader known for the ability to precisely execute to strategic corporate objectives in a performance driven, accountable culture.Expertise in global regulatory and quality management system schemes, including but not limited to the subscribing countries to the Medical Device Single Audit Program (MDSAP).Experienced in, and working knowledge of, EU Medical Device Regulations (MDR), including gap assessment/QMS remediation to achieve MDR compliance, labeling review and revision, technical documentation, clinical evaluation and post-market surveillance/post-market clinical follow-up.Leader of interactions with global regulatory authorities regarding product registrations, manufacturing/processing, quality, labeling and compliance issues in support of creating new marketing opportunities domestically and abroad.Product experience covering a broad range of clinical and therapeutic areas including patient monitoring/analytics, orthopedics, sports medicine, general surgery and dental surgery.Technology experience includes implantable medical devices, patient monitoring devices, electromechanical/rehabilitative devices, human tissues and animal tissues.

Listed skills include Medical Devices, Regulatory Affairs, Fda, Iso 13485, and 13 others.

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  The University Of Tennessee At Chattanooga

  Nursing