Carole Coles Email & Phone Number

Memphis, Tn, Us

Clinical evaluation reporting for medical device manufacturers. US and EU medical device regulation, compliance, marketing and quality. Safety and effectiveness of products for ophthalmology, otolaryngology, rhinology, respiratory, sleep medicine, orthopedics, and sports medicine. Analysis and preparation of concise reports with accuracy and precision. Fulfills experience requirement listed in Article 15 of the EUMDR for person responsible for regulatory compliance.

Watford, Hertfordshire, Gb

Research and write Clinical Evaluation Reports to provide evidence of product safety and performance per MEDDEV (MDD) 2.7/1 revision 4 Guidelines for Medical Devices regulated by directives 90/385/EEC and 93/42/EEC. (Also employed by S&N 1989 - 2003 Clinical, Regulatory, Analysis)

Manage Quality Systems for Medical Device Manufacturing per ISO 13485. Conduct audits, prepare standard operating procedures (SOP), provide employee training and perform regulatory consulting.

Center Valley, Pennsylvania, Us

Upstream marketing of ear, nose and throat (ENT) surgical instruments. Launched products integrating technology with Olympus Germany, Olympus Tokyo and BrainLab. Surgical simulation testing and training labs. Planned and executed marketing, business development and educational initiatives. Transcribed technical meetings. Corrective and Preventive Action (CAPA) and complaint management. Olympus Surgical Technologies of America / Gyrus / ACMI / formerly Smith & Nephew Richards Medical ENT Manufacturing facility, Bartlett, TN.

Watford, Hertfordshire, Gb

Implemented sales strategies, managed sales promotion programs, obtained feedback from the sales force, analysis and reporting. Orthopedic, trauma and reconstructive medical devices and instruments.New products launched achieved $150 million in sales.Performed complex analysis and reported findings in simplified terms. "Above and beyond" accomplishments on cross-functional teams.

Watford, Hertfordshire, Gb

Prepared regulatory documents. Analyzed testing, labeling, compliance and conducted due diligence audits. Division achieved fastest US government approval in the industry. Recruited surgeons and achieved participation goal in outcomes studies.Incorporated clinical study protocols into physician practices. Hosted clinician meetings to further knowledge of surgical procedures and patient conditions.Exceeded expectations with an exemplary customer focus.

Master Of Health Administration; Bachelor Of Science Biology

Education record