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- 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.
- 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.
Regulatory Affairs Assistant - Surrey, United Kingdom - X4 Life Sciences
Description
Job Description
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:
Qualifications and Skills:
Please share you CV at e. 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.