Regulatory Affairs Associate

Contract: Minneapolis, Minnesota, US

Salary: $35.00 Per Hour

Job Code: 330408

End Date: 2023-04-25

Job Status: Expired

This Job is no longer accepting applications

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL -, email your updated resume at or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

  • The Electrophysiology (EP) Regulatory Affair Associate will work from our St Paul location support the regulatory department to ensure efficient and compliant business processes and environment.
  • In this role, you may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.
  • You will participate in preparing and submitting documentation needed for registration worldwide, with a focus on Latin America.

Key Responsibilities:

  • Ensure our products and procedures comply with applicable regulatory agency requirements and guidelines;
  • Responsible for review Product Release activities in Windchill including maintaining accurate master data, and support any other assigned projects such as data clean up.
  • Support GMP certificate and in country certificates activities.
  • Work with cross-functional teams to support regulatory submission, change management and product release activities.
  • Manages concurrent deadlines and meets deadlines for assigned work/tasks.
  • Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.


  • BA or BS degree in health science, regulatory, business, engineering or equivalent combination of education and work experience.
  • Ability to manage projects and drive them to completion with attention to detail.
  • Requires ability to be innovative, resourceful, and work with minimal direction.
  • Strong written and verbal communication, at all organizational levels.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Experience working in medical device industry with focuses on regulatory, or quality systems preferred.
  • Strong problem-solving skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
  • Skilled in MS Office specifically Excel, PowerPoint, and Word.


  • Fluency in Spanish and/or Portuguese desired, but not required
  • Experience in regulatory affairs preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area, especially if it is in the medical device industry.


Job Requirement
  • Regulatory Affairs Associate
  • Regulatory Affairs
  • Electrophysiology
  • medical device
  • Quality Management Systems
  • Environmental Management Systems
  • regulatory
  • business
  • engineering
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • 4255231648
This Job is no longer accepting applications
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