Clinical Specialist

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$80,000.00/yr - $/yr

We have a Med Device (Life Sciences) client in Burnsville MN looking for a Clinical Evidence Specialist. This direct role with them offers competitive pay and full benefits!

The Clinical Evidence Specialist will combine an understanding of medical device regulations and guidelines and product knowledge to support regulatory submissions in the US and Europe. This role will be responsible for supporting clinical activities related to device development during both pre-market and post-market phases. The Clinical Evidence Specialist is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, CER, PMCF Plan, SSCP and literature review).

Responsibilities

• Oversees the clinical evaluation process for multiple cardiac medical devices in compliance with applicable clinical and regulatory standards and alignment with business needs.
• Provides scientific and/or medical expertise, analytical thought processes, and a robust, systematic clinical evaluation approach to continuously collect, analyze, and assess clinical data on Cardiac Rhythm (CRM) products throughout their lifecycle.
• Collaborates with cross-functional teams on establishing clinical safety and performance objectives for medical devices and defining the associated appraisal and analysis plans for various types of data sets across the lifecycle of the medical device.
• Plans and develops clinical evaluation plans, reports, post-market clinical follow-up plans, and reports, a summary of safety and clinical performance, and other related deliverables.
• Plans and conducts comprehensive literature searches.
• Manages project schedules for each document to ensure timely execution.
• Communicates cross-functionally with multiple stakeholders in the company including regulatory, marketing, and product development as well as external vendors such as CROs and Reviewers.

Qualifications

• 2-4 years of clinical/medical/scientific writing experience.
• Strong understanding of regulatory requirements & experience in writing regulatory reports including Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Post Market Clinical Follow-Up (PMCF) Plan.
• Experience in clinical evidence planning and/or development (e.g. identifying data needed to substantiate claims, developing literature search protocols, etc.).
• Experience in cardiovascular disease device therapies preferred.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• 85% of the time requires viewing and working at a computer screen.
• Significant work pace & pressure due to deadlines.

Pay Range: $80,000 - $100,000 a year

Benefits: Medical, Dental, Vision, 401K, PTO, Long Term and Short Term Disability, and more!

Entry level

Full-time

Health Care Provider

Business Consulting and Services