Regulatory Affairs Specialist

Contract: Plymouth, Minnesota, US

Salary Range: 27.00 - 33.00 | Per Hour

Job Code: 356504

End Date: 2025-01-10

Days Left: 13 days, 18 hours left

Job Description:

About the Role:
Join our Structural Heart Division as a Regulatory Affairs Associate, where you will play a pivotal role in managing and resolving complaints related to adverse events, malfunctions, and customer feedback. This entry-level position is ideal for motivated individuals looking to grow their career in the medical device industry.

Key Responsibilities:

  • Document, code, and analyze complaints to identify trends and maintain compliance with regulatory standards.
  • Handle complaints from sales teams, customers, and healthcare professionals, ensuring timely and accurate resolution.
  • Collaborate with cross-functional teams to manage complaint files and follow established procedures.
  • Apply time management skills to meet deadlines and effectively manage workload.
  • Assist in coding complaints and drafting detailed procedure descriptions.

Qualifications:

  • Education: Bachelor’s degree required; a degree in Sciences is preferred.
  • Experience:
    • 1–3 years of experience in a related field.
    • Complaint handling experience is a plus.
    • Regulatory, clinical, medical, or QA experience is advantageous.
    • Customer service, claims processing, or high-volume workload experience is beneficial.
  • Skills:
    • Proficiency in Office Suite.
    • Strong adaptability, motivation, and self-teaching ability.
    • Exceptional time management and organizational skills.

Preferred Experience:

  • Exposure to the medical device industry.
  • Familiarity with regulatory and quality assurance standards.

Pay Range : $27/hr. - $33/hr.

Job Requirement
  • Regulatory Affairs
  • Quality Assurance/Quality Control
  • Clinical Research
  • Excel
  • Documentation
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Vishnu Nair
  • vishnu.nair@collabera.com
Apply Now
Apply Now
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