SUMMARY OF DUTIES
This position is responsible for creating and implementing regulatory and clinical strategic plans that meet the organizationï¿½s goals of introducing new and existing products into a global market with minimal direction from management.
“Must be vaccinated against COVID-19, unless otherwise prohibited by applicable law. You must have received your first dose of COVID-19 vaccination by your first day of employment, and for two-dose COVID-19 vaccines, you must receive your second dose within thirty days of your first day of employment. Merit will consider exemption requests in accordance with federal, state, and local laws.” ESSENTIAL FUNCTIONS PERFORMED Determines and documents global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required 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, delivers, and defends regulatory submissions to the FDA, the Notified Body, and other regulatory authorities and/or distributors. Prepares documentation for Clinical Studies, as needed. Reviews significant product and clinical study submissions with management and negotiates submission issues with agency personnel. Provides support to currently marketed products as necessary by reviewing/approving labeling, promotional materials, and 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, Notified Body audit, product recalls, etc., as needed. * Maintains proficiency in worldwide regulatory requirements; establishes and maintains positive relationships with agency personnel and/or Regulators.
- Provides business and product information to international regulatory staff to enable the development of strategies and requirements, and communicates that information to management and project teams.
- Provides feedback and ongoing support to product development teams for regulatory issues and questions and informs management of status and developments on projects.
- May develop, maintain, and analyze department systems and provide training.
- May ensure personal understanding of all quality policy/system items that are applicable.
- May assist with departmental policy implementation.
- Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams.
- May identify relevant standards and guidance documents that affect Meritï¿½s business and products.
- May assist with Regulator facility inspections.
- May conduct internal audits, when directed.
- May assist with risk management review and documentation.
Performs other related duties and tasks, as required. SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelorï¿½s Degree in a technical field such as the biological, physical, engineering, or material science disciplines.
- Seven years of relevant regulatory experience.
- Demonstrated or verifiable experience with authoring regulatory submissions and interacting with reviewers.
- Demonstrated knowledge of global regulatory requirements such as, U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Medical Device Regulation (2017/745), ISO 13485 Quality System Standard, ISO 14971 Risk Management, 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.
- Supervisory/mentoring and project management skills
- Global knowledge of medical device regulations/law
- FDA/Notified Body communication
- Problem solving
- Field Action coordination and reporting
- Product development and change qualification processes
- Regulatory submission/rationale preparation
- Interpersonal/communication skills
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. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at www.youtube.com/meritmedical to see the video titled “Great people, Great products, Great Company”. Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.
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. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. 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. www.merit.com/careers EQUAL OPPORTUNITY EMPLOYER M/F/D/V LI-MM1 PandoLogic. Category: Marketing & Biz Dev, Keywords: Regulatory Compliance Specialist0 – 0