Associate Regulatory Specialist Job at Planet Pharma, Minneapolis, MN

YUdPTVpCVU1CSkxpSWZrdzVOVWtTNms0MXc9PQ==
  • Planet Pharma
  • Minneapolis, MN

Job Description

Top 3 things the manager is looking for in a candidates experience:

  1. strong attention to detail
  2. strong analytical skills (problem solving, critical thinking)
  3. strong writings skills

What are the top 3 Tasks or Responsibilities in scope for this role:

  1. document and evaluate product feedback and product analysis results for company products to determine complaint status
  2. compile regulatory agency reports for submission
  3. monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation

Education Required: Bachelor’s

Years’ Experience Required: a few months-2 years’ experience. Prefer some job experience but open to interviewing recent graduates.

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.

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.

Job Tags

Similar Jobs

DSJ Global

Senior Controls Engineer Job at DSJ Global

 ...Physical ability to climb ladders, work in dusty environments, and lift up to 50 pounds. Travel & Location: Travel to customer sites (20-25%). Potential to be based in Welcome, MN / Mankato, MN / Edina, MN, with remote or hybrid work options after training.... 

Insight Global

Help Desk Specialist Job at Insight Global

 ...coursework. * Associate's Degree * Candidates must be available to work daytime and evening hours during the week and on some weekends as part of their normal, permanent schedule * Ability to demonstrate professional verbal communication skills * Ability to quickly... 

Piper Companies

Associate Account Manager Job at Piper Companies

 ...Account Manager will work through a sales training program built for...  ...hospitality, sales or related internship, or active participation in a...  ...health insurance ; medical, dental, vision, and life ~4...  ...uncapped commission, unlimited paid time off, unlimited PTO, hybrid... 

LevelUp Consulting, LLC

Landscape Architect Job at LevelUp Consulting, LLC

 ...LevelUp Consulting is a civil engineering, planning, and landscape architecture consulting firm specializing in the civil engineering...  ...development industry. We are seeking a mid to senior level landscape architect . The applicant will lead or assist in the design,... 

KET - Kentucky Educational Television

Summer 2025 Development Internship Job at KET - Kentucky Educational Television

 ...or prior employers are required with your resume submission. Summer 2025 Intern Work Plan Application deadline: April 15th...  ...following: Silent Auction Photography of packages/items for online bidding platform Proof/edit/create bid cards. Ensure item codes...