Regulatory Affairs Manager


About this role: Regulatory Affairs Manager

Brunel is hiring for a Regulatory Affairs Manager to support our rapidly-growing client, a medical device client based in the Dallas-Fort Worth region. This role will ensure clearance and compliance for all products across all markets. The Regulatory Affairs Manager will be responsible for the well-established, full product portfolio of the organization, as well as new submissions.

  • Oversee the regualtory function for full product portfolio, managing a team, department and budget
  • Coordinate regulatory submissions in US and OUS markets
  • Liaise with regulatory authorities
  • Provide regulatory input/support for audits
  • Regulatory strategy for product development
  • Work closely with cross-functional teams


  • 5+ years of progressive regualtory affairs experience
  • Minimum of a Bachelor's Degree in related field
  • Submissions experience - EU and International markets
  • FDA experience preferred (510(k))
  • Willingness to be on-site when required
  • Desire to build a growing team and lead


Why apply through Brunel? Finding the next step in your career can be a fulltime job. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We will get you going while you get on with the job.

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Brunel has a reputation for working with some of the best in the business. That is what we continually strive for. Over 45 years, we have created a global network of interesting clients and talented individuals working together through a vast array of services.

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Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
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Any questions remaining?

Your consultant, Lisa Gardiner is happy to clarify anything about this vacancy. When reaching out, use the pub number:

Account manager

Lisa Gardiner
Brunel USA - Boston