Regulatory Affairs Manager

MRIGlobalSearch; North East; On-site; GBP 60,000 - 80,000; Full time

Job summary

A healthcare consulting firm in the Northeast of England is seeking a Regulatory Affairs Manager to oversee regulatory compliance in a fast-paced medical device environment. The ideal candidate will have over 5 years of medical device regulatory experience, knowledge of 510K submissions, and the ability to manage a team. This role offers a significant opportunity to impact the business's regulatory strategy.

Benefits

Impactful role in a growing company

Supportive CEO

Expansion opportunities

Qualifications

• 5+ years of experience in regulatory affairs.
• Experience with EU technical files.
• Hands-on and strategic approach to team management.

Responsibilities

• Oversee regulatory compliance for medical devices.
• Manage a team of 5-6 regulatory professionals.
• Drive the submission of 510K applications.

Skills

Medical device regulatory experience

Experience with 510Ks

International regulatory experience

Team management

Strategic thinking

Job description

Find a position that matches your potential.

Northeast

Regulatory Affairs Manager

Our client is a privately-held group of medical device/pharma manufacturing and distribution subsidiaries. They are currently seeking a Regulatory Affairs Manager to join their team in the Northeast.

What’s in it for you…

• Fast-moving medical device/pharma/dental company – expanding operations and product lines
• CEO is committed to the employees and their success
• Can make a large impact on the business and the regulatory team

To be considered for an interview, the following experience/skills are desired:

• 5+ years experience
• Medical device regulatory experience
• Experience with 510Ks
• International regulatory experience, EU technical files
• Comfortable managing a team of 5-6; hands on and strategic

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