Assoc MDR/Vigilance Specialist
8200 Coral Sea Street Northeast Mounds View, MN 55112 US
Work Location: Hybrid M/T/F virtual W/Th in office in Mounds View MN
Top 3 things the hiring manager is looking for:
- Analytical reading/writing with excellent communication skills
- Strong attention to detail
- Relevant experience in a related field
Top 3 Tasks or Responsibilities in scope for this role:
- Electronically process events
- Perform tasks to obtain adequate information for proper documentation and closure of the event
- Collaborate with technical, clinical, field, and other company employees to determine reportability
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. In addition, this position supports the ongoing monitoring of product performance.
Works cross-functionally to ensure maintenance and review of events and reporting of regulatory reports, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports and represents complaint handling in internal and external audits and inspections.
As part of the Cardiovascular Customer Quality Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.
This process is governed by the FDA Quality System Regulations (QSR) Guidelines, ISO 13485:2003, Good Manufacturing Practices (GMPs), and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. This position requires the individual to be a main contributor to product quality improvement efforts and be the main contact to our customers on complaint issues. In addition, this position will analyze customer complaints to determine which are regulatory reportable, will generate and submit the regulatory reports within the government mandated timelines, and is a key contact for activities with internal, field, and end user customers.
Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure.
We are comprised of three key businesses: Cardiac Pacing Therapies, Cardiovascular Diagnostics & Services, and Defibrillation Solutions.
A Day in the Life
In general, the following responsibilities apply to the MDR/ Vigilance Specialist role. This includes, but is not limited to the following:
• 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.
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) and 2 years of relevant experience, or advanced degree with 0 years of experience.
Nice to Have
- Previous MDR experience
- Product knowledge
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.