Regulatory Affair Specialist

Location: Minneapolis, Minnesota Salary: US$40 - US$45 per hour
Sector: Pharma & Biotech, Medical Devices, Regulatory Affairs (RA) Type: Contract

Do you have a strong background within Regulatory Affairs? Are you interested in working at a leading non-invasive medical device company? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, a global market leader in designing and manufacturing noninvasive patient monitoring devices for healthcare professionals and individual users, is actively searching for a Regulatory Affairs Specialist to join its team in Plymouth, Minnesota. This will be structured as a 6 month contract. They are looking for a Regulatory Affairs Specialist to provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions.

Among others, this role will take on the following responsibilities:

  • Prepare worldwide submissions for new products and any product changes as needed to ensure timely approval for market release
  • Find, interpret, and prepare regulatory strategies and worldwide compliance requirements
  • Documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, project schedules, approvals, renewals, and change orders.

The best candidates for this role will possess the following basic qualifications:

  • B.S. degree in Science or Engineering, related technical field
  • 3+ years of experience in the medical device industry
  • Experience submitting and authoring 510k
  • Thorough understanding of FDA and international submission requirements including how to comply with standards and regulations
  • Experience & knowledge of U.S., Latin American, and Asia Pacific regulations

The Regulatory Affairs Specialist is an outstanding opportunity to take on immediate leadership and grow within a top notch organization, and Plymouth, MN is a fantastic location!

If you are interested in learning more and/or applying, please reach out to me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.