Regulatory Affairs Specialist

Regulatory Affairs Specialist focuses on as the new regulatory affairs specialist, you will support the ongoing development, maintenance and execution of regulatory activities across the business.

What the role involves

• As the new Regulatory Affairs Specialist, you will support the ongoing development, maintenance and execution of regulatory activities across the business.
• This is a hands-on role with exposure across the full product lifecycle, working closely with internal teams to ensure products remain compliant across multiple global markets whil.
• Maintain the Quality Management System in line with ISO 13485 requirements.
• Maintain technical documentation across MDD, MDR, IVDR, UKCA, FDA and procedure packs.
• Ensure ongoing compliance with applicable regulatory requirements and standards.
• Supporting document control activities including procedures, labelling and product documentation.

Skills and requirements

• Proven Regulatory Affairs experience within the medical device industry.
• Experience supporting regulatory strategy and submissions activities.
• Working knowledge of MDR and FDA regulatory frameworks.
• Experience working with technical documentation and regulatory files.

Confirmed role details

• This is a hybrid role with the expectation of being Onsite once or twice a week in Uxbridge.

Additional role context

• Cure Talent are delighted to be partnered with a growing medical device manufacturer with a broad and diverse product portfolio across areas including IV therapy, diabetes care, su.