This position is responsible for implementing regulatory and clinical strategic plans that meet the organization's goals of introducing new products into a global market.
* Teams with Corporate and International Regulatory staffs to provide support for new products and changes to existing products.
* Works with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
* Prepares FDA submissions, Technical Files, Canadian Applications and International Dossiers for new products and product changes.
* Prepares documentation for Clinical Studies and coordinate and maintain study communications.
* Reviews significant product and clinical study submissions with management and negotiate submission issues with agency personnel.
* Provides support to currently-marketed products as necessary by reviewing labeling, promotional materials, and product and documentation changes per policy and procedure.
* Interact directly with the FDA and/or indirectly with international regulatory agencies on most products/projects at reviewer level; all significant issues will be reviewed with management.
* Supports regulatory compliance activities, including manufacturing site registration, GMP, Notified Body audit, post market vigilance reporting, product recalls, etc., as needed.
* Maintains proficiency in worldwide regulatory requirements; establishes and maintains positive relationships with agency personnel.
* Provides business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to management.
* Provides feedback and on-going support to product development teams for regulatory issues and questions.
* Ensures personal understanding of all quality policy/system items that are applicable.
* Performs other related duties and tasks, as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
* Lifting -- Not to exceed 50 lbs -- local practice may apply * Writing * Sitting * Standing * Bending * Vision * Color perception * Depth perception * Reading * Field of vision/peripheral * Fine motor skills
SUMMARY OF MINIMUM QUALIFICATIONS
* Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines.
* Seven years of regulatory experience, with three of those years of pre and post market clinical trials.
* Must have experience working with the strategic planning and crafting of Class III medical device submissions in the US.
* Experience working with principal investigators, research coordinators, IRBs and ethics committees is preferred.
* Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC) ISO 13485 Quality System Standard and Canadian Medical Device Regulation.
* Self-motivated, self-directing, strong attention to detail and excellent time management skills.
* Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.
* Excellent analytical and problem solving skills.
* Demonstrated excellent in submission writing and preparation.
* Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
* Global knowledge of medical device regulations/law
* FDA/Notified Body communication
* Problem solving
* Recalls/MDRs/vigilance reporting/mandatory problem reporting
Founded in 1987, Merit Medical set out to build the world’s most customer-focused healthcare company by understanding customers’ needs, and innovating and delivering a diverse range of products that improve the lives of people, families, and communities throughout the world.
Merit’s primary products consist of inflation devices used in angioplasty and stent placement; diagnostic and therapeutic... catheters used for various procedures in cardiology and radiology; diagnostic and hydrophilic products used to manage and monitor the administration of contrast media and other fluid solutions; thrombolytic catheters and fluid dispensing systems; and embolotherapeutic products for the treatment of uterine fibroids, hypervascularised tumours, and arteriovenous malformations; and procedural trays, packs, and kits.
Merit maintains a diverse, multi-campus manufacturing footprint in North America and Europe with a true global distribution network focused on delivering our products and technologies to our customers.