SUMMARY OF DUTIES

Responsible for supporting the development and creation of clinical, scientific and regulatory documents in accordance with procedures, European Medical Device Regulations, and US FDA requirements. The primary focus will be on Clinical Evaluation Reports (CERs) and Summaries of Safety and Clinical Performance (SSCPs).

ESSENTIAL FUNCTIONS PERFORMED

• With minimal oversight, researches, prepares, writes, edits and reviews clinical evidence documents, e.g. CERs and SSCPs.

• Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.

• Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.

• Collaborates with cross-functional teams to ensure high quality and successful project delivery.

• Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.

• Provides input to post-market surveillance and risk management activities.

• Creates and manages a schedule of deliverables.

• Performs other duties and tasks, as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelors' Degree in the medical, biological, physical or engineering disciplines and three years of medical writing experience, preferably with CERs.
• Knowledge of regulatory requirements relative to Clinical Evaluation Reports.
• Experienced in searching medical literature and databases for clinical and technical information.
• Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information and complex documents.
• Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards.
• Effective written and verbal communication skills in the area of technical/clinical applications.
• Strong command of medical and surgical terminology.
• Working knowledge of statistics.
• Self-motivated, self-directing, strong attention to detail and excellent time management skills.
• Project management skills.
• Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs.

COMPETENCIES

• Medical/technical writing skills
• CER protocol and report development/writing
• Medical literature research skills
• Computer skills
• Interpersonal/verbal/written communication skills
• Project management skills
• Statistical knowledge/application

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

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At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

As an eligible Merit employee, you can expect the following:

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

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Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.