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.
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.
How to apply
If you meet the above requirements and would like to be considered for this role, please submit your interest using the ‘Apply’ button. Applying is quick and easy – just make sure you have the following documents ready to go:
- Cover Letter (optional)