Regulatory Affairs Assistant

I am excited to present an exciting opportunity for a Regulatory Affairs Specialist to join a world leading Medical Device organisation. This role offers the chance to make a significant impact in ensuring the safety and compliance of cutting-edge medical devices and products, contributing to the advancement of healthcare and patient outcomes.

Duties and Responsibilities:

• Preparation of regulatory submissions to secure global market clearance, focusing on meticulous compliance with all relevant standards.
• Actively support product clearance through navigation of US FDA, EU (IVDR), and other global regulatory frameworks, ensuring seamless market entry and sustained compliance.
• Engage in critical processes such as Design Control, Risk Management, Post Market Surveillance, and change control, contributing to the product's lifecycle management with a keen eye for detail and quality.
• Take charge of producing, reviewing, and maintaining product technical files, ensuring they adhere to global regulations and standards, thus upholding the highest levels of product integrity and safety.
• Update and review product Instructions for Use (IFUs), packaging, and promotional labelling, ensuring accurate, compliant, and user-friendly information is always provided.
• Provide essential regulatory intelligence to the business, keeping the team ahead of regulatory trends and changes, ensuring proactive compliance strategies.
• Collaborate closely with the Quality department to maintain the ISO 13485 QMS and FDA 21CFR part 820 QSR, along with supporting the ISO 15189 accreditation of the Clinical laboratory, showcasing a commitment to excellence and continuous improvement.
• Assist in conducting both internal and external audits.

Qualifications and Skills:

• A degree in Science or Engineering.
• A minimum of 2 years of Regulatory experience within the medical device or pharmaceutical environment.
• RAC certification is preferred, indicating a deep understanding of regulatory affairs and a commitment to professional development.
• Experience with ISO 13485, FDA 21CFR medical device, and IVD codes, evidencing a robust knowledge of critical regulatory frameworks.
• Experience dealing with Notified Bodies and global regulatory authorities is preferred, demonstrating an ability to effectively communicate and negotiate with key stakeholders.
• A commitment to high-quality data, reflecting a dedication to accuracy and reliability.

Please share you CV at e.smailes@x4 lifesciences.com if you are interested in hearing more about the position. As always if anyone in your network may be a good fit, please share their details as we offer a referral bonus upon the successful placement.