OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a MDR / Vigilance Specialist in Mounds View, MN.

In the MDR / Vigilance position, you will participate in the company's medical device surveillance platform, including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports.

The MDR / Vigilance Specialist analyzes events reported from multiple inputs on Cardiovascular products to determine complaint status and regulatory reportability.

Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.
• Ensure complaint investigations are adequate, accurate, detailed, and timely.
• Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
• Collaborate with appropriate technical, Clinical, Field / Sales and / or returned product analysis employees to determine reporting eligibility.
• Complete electronic submission of MDRs to the FDA.
• Ensure accurate data entry, scanning, and retention of documents to complete event files.
• Support internal systems, methods, and procedures to maintain compliance.
• Develop and maintain product knowledge of CRHF products.
• Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information.
• Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling.
• Complete projects as assigned and required specific to post-market quality and complaint handling.

EXPERIENCE

2 years of relevant experience, or advanced degree with 0 years of experience.

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

EDUCATION

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. .2(h)(iii)(A)

To be a best-fit your strengths must include :

• Excellent verbal and written communication skills, especially the ability to communicate complex analytical techniques in a way that is understandable by non-quantitative audiences
• Strong attention to detail
• Organized, Self-Motivated, and goal oriented.
• Experience in healthcare
• Legal experience

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit