Clinical Evidence Specialist

3 weeks ago

Denver, United States Merit Medical Systems, Inc. Full time

Work Shift:

DAY

Work Schedule:

Why Merit?

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.

SUMMARY DETAILS

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 on 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

1. With minimal oversight, researches and prepares PMCF plans and reports, including data synthesis and critical analysis.

2. Participates in the development of pre-market and post-market clinical evidence strategies and cross-functional teams.

3. Supports product development teams on issues relating to pre-market and post-market clinical evidence needs and strategies for global markets.

4. Build relationships with key stake holders and ensure clear understanding of responsibilities and deliverables for PMCF activities.

5. Work with key stakeholders and meet PMCF activity deliverables.

6. Create PMCF Evaluation Reports to document the outcomes of PMCF activities.

7. Draft and assemble documentation as required for internal records and regulatory submissions.

8. Work independently to balance competing priorities and drive results with limited supervision.

9. Performs other duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

* Lifting -- Not to exceed 50 lbs. - local practice may apply.
* Writing
* Sitting
* Standing
* Bending
* Visual acuity
* Color perception
* Depth perception
* Reading
* Field of vision/peripheral

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.

PREFERRED QUALIFICATIONS

* Advanced degree in a medical or scientific discipline.

COMPETENCIES

* 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

COMMENTS

Infectious Control Risk Category III:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

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.

Military Veterans are encouraged to Apply.

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

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