Director of Clinical Affairs – Medical Devices – FILLED
Director of Clinical Affairs – Medical Devices
The Wellington Group has been engaged to find an experienced Clinical Affairs Director with a strong medical device / device trials management background. This is a great opportunity to work for one of the industries leading medical device companies with a focus on current and future technologies.
The Director, Clinical Affairs is responsible for being a source of Clinical advice as required on matters relating to the development, marketing, clinical performance and regulation of the company’s products.
- Reviews, obtains, or otherwise provides clinical input on content of package inserts, instructions for use, surgical techniques, brochures, videotapes, advertisements, product bulletins, literature, first human use reviews, etc.
- Reviews and advises on new technology/product ideas; on pre-clinical testing and clinical research protocols; provides opinion on new products.
- Provides and/or obtains medical input on decisions regarding recalls or other remedial actions on distributed products.
- Assists in the establishment of advisory boards and physician review groups, participating when appropriate.
- Provides medical input to legal counsel on product litigation, claims management, investigations, and other matters demanding medical expertise.
- Assists marketing group with clinically related advice in the preparations for symposia, trade/medical shows, and similar outreach, educational or training programs.
- Provides clinical input regarding product attributes to management on rework issues.
- Coordinates Clinical Affairs’ involvement in clinical and pre-clinical research.
- Ensures compliance with regulatory standards regarding clinical affairs and industry’s involvement with clinical affairs. Regulatory standards including the Food and Drug Administration (FDA), and the American Medical Association (AMA), HIPPA and AdvaMed Guidelines.
- Interfaces with Marketing and Sales to ensure that the company’s clinical affairs activities are in line with overall corporate goals.
The qualified candidate will have:
- Bachelor’s Degree in Health Science, Business, Nursing, or related field required.
- Master’s degree preferred.
- Certified Clinical Research from ACRP or SOCRA certification preferred.
- Five (5) years experience dealing with issues relating to medical, regulatory or related responsibilities in a medical device company.
- Clinical experience with medical device products and associated surgical procedures essential.
Industry: Medical Device, Biotechnology, Combination Products
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)