Regulatory Affairs Associate

Junior Regulatory Affairs Specialist
Location: North West London
Contract Type: Permanent
Salary: £30,000 - £35,000

Are you looking to kickstart your career in the medical device industry? Join a growing QARA team in an innovative company that’s making strides in global markets!

My client is expanding globally and working on obtaining FDA and MDR approvals for its cutting-edge medical devices. With a close-knit QARA team of 5-6 members, you’ll have the opportunity to contribute to impactful projects while enjoying excellent career progression.

Key Responsibilities

• Assist in securing regulatory approvals for new and existing medical devices, focusing on MDR and FDA compliance.
• Support the preparation, review, and submission of regulatory documents.
• Collaborate with cross-functional teams to address compliance challenges.
• Stay updated on regulatory changes and their impact on products and processes.
• Contribute to internal and external audits as required.
• Opportunities to develop technical expertise and regulatory knowledge.

Key Skills and Qualifications

• Background in Medical Devices.
• Basic understanding of MDR/FDA regulations.
• Knowledge of medical devices and ISO13485 compliances.
• Additional training or certifications in Regulatory Affairs or Medical Devices

Benefits

• Competitive salary.
• Pension and private medical insurance.
• Flexible work-from-home Fridays.
• Clear career progression pathways.

What We’re Looking For

We’re seeking an honest, intuitive, and ambitious individual who’s eager to learn and grow in the regulatory affairs field. If you’re passionate about contributing to innovative medical device projects and thrive in a collaborative environment, this role is for you!