SUMMARY OF DUTIES
Responsible for coordinating, preparing, and maintaining regulatory submissions and documents for Europe. Primary responsibilities are to ensure regulatory compliance for assigned product lines with the European Medical Device Regulation (MDR). Performs duties with limited input from management and/or senior members of the department.
“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 * Converts MDD-compliant Technical Files to MDR-compliant Technical Files. Performs gap assessment for requirements to MDR and oversees remediation in a timely manner.
- Works with various departments to define MDR remediation requirements of E.U. Technical Files or regulatory rationales and implements solutions.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Interacts with various levels of management, external agencies, consultants, and companies.
- Remains current on developing regulations and revises systems, as necessary.
- Assists with supervision of department staff, as directed.
- 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 and six years of related industry experience.
- Demonstrated knowledge of the E.U. Medical Device Regulation (MDR), and pertinent Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers. 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.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
- MDR-compliant Technical File creation
- Regulatory submission/rationale preparation
- Global Regulatory paths/strategies
- Computer skills/internet research
- Interpersonal/communication skills
- Regulatory system development/training
- Product development and change qualification processes.
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 Specialist00 – 0