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Assoc MDR/Vigilance Spec - Exempt

HireTalent

Mounds View, MN

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JOB DETAILS
SKILLS
Adverse Events, Analysis Skills, Anatomy, Biology, Biomedicine, Biotech and Pharmaceutical, Clinical Assessment, Clinical Data, Clinical Medicine, Communication Skills, Customer Relations, Data Analysis, Database Analysis, Detail Oriented, FDA Requirements, Government Regulations, Government Requirements, Healthcare, Leadership, Legal, Medical Equipment, Medical Records, Mentoring, Neurology, Neuroscience, Nursing, Patient Care, Pharmacovigilance, Physiology, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Product Documentation, Product Reviews, Product Testing, Project Design, Project Tracking, Project/Program Management, Protocol Analysis, Regulations, Regulatory Reports, Regulatory Requirements, Safety/Work Safety, Surveillance, Talent Management, Time Management, Writing Skills
LOCATION
Mounds View, MN
POSTED
30+ days ago


Nice to Have:

nursing or biomedical background

JOB DESCRIPTION

Max BR: ***/hr

HM's Top Needs:

1. Nursing/medical backgrounds (ideally with clinical experience working with medical devices)
2. Biomedical engineering or biomedical neuroscience backgrounds (education without on-the-job experience is sufficient)
3. Pre-med, pre-vet educations (essentially, any degree with a heavy focus on biological sciences including anatomy, physiology, etc.)


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? Mounds View, MN
Does this person need to be on site? If so, full time or part time? Onsite 4 days/week, remote 1 day/week


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 our client 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 of science 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 nursing, biology/pre-med or pre-vet, or biomedical 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




Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations. Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems. Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A job at this level is focused on self-development. Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced 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. 214.2(h)( 4)(iii)(A), 0 years of experience required.

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