Merit Medical Systems, Inc.
About the job
SUMMARY OF DUTIES*
This position develops, documents, and executes pre-market and post-market clinical evidence strategies for medical devices across product platforms. Works with cross-functional teams and key stakeholders to execute clinical evidence strategies for specific products/product families. For established products in the EU market, writes post-market clinical follow-up (PMCF) plans and documents safety and performance outcomes in the PMCF Evaluation Report in support of MDR.
Essential Functions Performed
- With minimal oversight, researches and prepares PMCF plans and reports, including data synthesis and critical analysis.
- Participates in the development of pre-market and post-market clinical evidence strategies and cross-functional teams.
- Supports product development teams on issues relating to pre-market and post-market clinical evidence needs and strategies for global markets.
- Build relationships with key stake holders and ensure clear understanding of responsibilities and deliverables for PMCF activities.
- Work with key stakeholders and meet PMCF activity deliverables.
- Create PMCF Evaluation Reports to document the outcomes of PMCF activities.
- Draft and assemble documentation as required for internal records and regulatory submissions.
- Work independently to balance competing priorities and drive results with limited supervision.
- Performs other duties and tasks, as required.
Summary Of Minimum Qualifications
- Education and/or experience equivalent to a Bachelors’ Degree in the medical, nursing, biological, physical or engineering disciplines.
- A minimum of three years of clinical research, clinical study, clinical data synthesis/analysis and/or clinical writing experience in the medical device field, preferably related to PMCF data collection and reporting.
- Knowledge of regulatory requirements relative to clinical investigations in at least one of the following regions: US, EU, other International (e.g., U.S. FDA regulations, the Medical Devices Directive [93/42/EEC, as amended], EU Medical Device Regulation [2017/745] and ISO 14155 Clinical Investigations standard).
- Experienced in searching medical literature and databases such as Embase for clinical and technical information.
- Ability to read, analyze, and interpret clinical literature, regulations, guidance documents, clinical and medical terminology, technical product information and complex documents.
- Effective written and verbal communication skills in the area of technical/clinical applications.
- Strong command of medical and surgical terminology.
- Working knowledge of statistics and their application to clinical studies.
- 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.
- Advanced degree in a medical or scientific discipline.
- General technical and/or medical device knowledge
- Medical/technical writing and data synthesis
- Medical device clinical research and/or clinical data analysis
- Clinical study design
- 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.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V