Regulatory Affairs Manager Jobs

Brunel is hiring for a Regulatory Affairs Manager to support our rapidly-growing client, a global 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.

You will:

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

Requirements:

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