Search Jobs
Assoc MDR/Vigilance Spec
8200 Coral Sea Street Northeast Mounds View, MN 55112 US
Job Description
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Mounds View, MN
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.