Virtual Assistant

1 month ago

Surrey, United Kingdom X4 Life Sciences Full time

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.

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