Regulatory Affairs Associate

JR United Kingdom; Worcester; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

A leading company in orthopaedic innovation is seeking a regulatory affairs specialist to bridge big ideas with regulatory-approved solutions. You will craft strategies, ensure compliance, and leverage your clinical expertise to shape future product designs. This role offers a flexible hybrid setup, with potential for fully remote work for the right candidate.

Qualifications

• Three+ years of solid regulatory experience in medical devices.
• Deep understanding of FDA and ISO frameworks.
• Confidence with submissions and global regulatory strategy.

Responsibilities

• Craft global regulatory strategies.
• Own FDA, ISO, and CE compliance.
• Build 510(k)s, PMAs, and other submission documents.

Skills

Regulatory experience

FDA knowledge

ISO frameworks

Submission confidence

Clinical expertise

Job description

Social network you want to login/join with:

If the sound of 510(k) doesn’t scare you…

If “ISO 13485” feels like a second language…

If you love the thrill of helping innovative medical devices cross the regulatory finish line…

Then you might be exactly who our client is looking for.

The Mission?

Join a team on the cutting edge of orthopaedic innovation! - You’ll be the bridge between big ideas and real-world, regulatory-approved solutions.

What you’ll actually do:

• Craft global regulatory strategies
• Own FDA, ISO, and CE compliance
• Build 510(k)s, PMAs, and other submission documents
• Be the go-to with agencies and auditors
• Keep tabs on all post-market surveillance and quality systems
• Use your clinical + technical expertise to shape future product designs

Join a fast-moving, forward-thinking team that is passionate about what they do!

You’ll need:

Three+ years of solid regulatory experience (ideally in medical devices)

Deep understanding of FDA + ISO frameworks

Confidence with submissions and global regulatory strategy

Location: Flexible hybrid setup – (Would consider fully remote for the right candidate)