European Union Regulatory Affairs, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
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.
ESSENTIAL FUNCTIONS PERFORMED
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 the 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.
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.
2 openings. Employer will assist with relocation costs.
Internal Number: 571-12903
About Merit Medical Systems
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies.
The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a ...direct sales force in Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.