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Assoc MDR/Vigilance Spec

New Brighton, MN 55112

Posted: 09/17/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 613532 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
1. Attention to detail

2. Critical thinking skills

3. Excellent written communication skills

 

Education Required: Bachelors Degree

Years’ Experience Required: 0-2 years

 

Will the contractor be working 40 hours a week? If not, weekly estimate? 40/week

Work Location: Mounds View Campus

                Do they need to be local to any MDT office and if so where?

Does this person need to be on site? If so, full time or part time? Mon/Tues on site/in-office, Wed-Fri remote





In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.

 

Neuroscience

The Neuroscience Portfolio group develops life-restoring therapies and healthcare solutions that span the neurological care continuum including integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

A Day in the Life

Responsibilities include the following but not limited to:
  • Apply policies and procedures to comply with FDA and OUS regulations.
  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
  • Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
  • Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
  • Maintain awareness of new products, government regulations and requirements.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
  • Other duties as assigned.

 

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.
  • Bachelor degree
  • High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
  • 0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation

Nice to Have
  • Degree in Health Care, Sciences, or Bio-Medical Engineering
  • Medical device industry experience
  • Strong verbal and written communication skills
  • Knowledge of basic anatomy and physiology
  • Strong attention to detail
  • High level of computer proficiency

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 Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About New Brighton, MN

Discover exciting job opportunities in the vibrant area surrounding New Brighton, Minnesota! Nestled in the Land of 10,000 Lakes, this charming city offers a perfect blend of small-town charm and big-city amenities. With its close proximity to the Twin Cities, job seekers can enjoy a plethora of career growth opportunities while savoring the unique culture and picturesque beauty of the region. Explore local landmarks like Long Lake Regional Park, catch a show at the historic Mounds Theatre, or cheer on the Minnesota Twins at Target Field. Don't miss out on the delectable cuisine, art galleries, and outdoor recreation this area has to offer. Take the next step in your career journey and browse our job listings in New Brighton, MN today!

Although this hasn't been an issue at Planet Pharma, 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 Planet Pharma.