LEX Diagnostics are recruiting for an organised Document Controller to join the team. In this role, you will be responsible for providing technical documentation guidance for FDA submissions, reviews, and inspections related to LEX Diagnostics Products.

LEX Diagnostics is an ambitious, well-funded point-of-care diagnostics business. We believe that fast, accessible molecular diagnostics will have a fundamental impact on how infectious diseases are managed at point of care and beyond. Our technology is uniquely able to address this challenge and we are commercialising it with partners who share our ambition. You can read more about LEX here.

As someone with a background in molecular biology and previous experience working on FDA approvals, you'll easily collaborate with the verification and validation team to ensure that the regulated documentation is in place to support with FDA approvals. You will receive support from the Quality Systems Manager and play an integral role as a valued member of the LEX Diagnostics team.

What you will be doing:

• Manage the Quality and Regulatory documentation workflows for the LEX Product portfolio and adhere to ISO13485 requirements.
• Coordinate and facilitate documentation reviews and approvals involving the relevant people.
• Assess the progress and effectiveness of the documentation control system, addressing any errors or discrepancies found.
• Generate and manage product technical documentation such as Design History Files (DHF), Device Master Records (DMR), Risk Management Files (RMF), and Device Master Files (DMF) in accordance with procedures.
• Identify and suggest enhancements to document control systems, offering continuous support and training to both new and existing LEX colleagues.
• Assist in developing and implementing document templates for Verification and Validation (V&V) activities.

Requirements

Previous skills and experience that would be useful to be successful in this role:

• Confident at using electronic Quality Management Systems.
• Strong communication skills and able to work in a multidisciplinary team.
• Logical approach to constructing documentation with great attention to detail.
• Able to liaise with notification and regulatory bodies for product listing and certification processes.
• Any experience with Salesforce and in particular, Dot Compliance would be a benefit but is not essential.
• Can solve documentation problems with tenacity and a sense of urgency.

Benefits

LEX Diagnostics is part of TTP Group, an employee-owned business. It operates from green surroundings in Melbourn, less than 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years. Drawing upon the expertise of its consultants in the Life Science sector, and the management experience of a company with a 30-year track record of developing breakthrough technology and creating ambitious tech businesses, TTP Group invested core IP and staff into LEX in 2020.

Our benefits include

• Annual profit-related bonus
• Employer pension contribution of 12% of pensionable pay
• Private medical insurance for employees and dependants
• Free lunch and all-day refreshments
• Life insurance worth 6 x salary
• 25 days holiday with the option to carry over or bring forward 5 days
• Enhanced maternity and paternity leave, with the option to return part-time for a year
• Electric car leasing scheme
• Cycle to work scheme
• Public Transport Season ticket loan
• A wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock band!
• Local sports facilities and theatre discounts and memberships as well as our own onsite gym to use

So, If you’re passionate about document management and eager to make an impact in the field of diagnostics, we'd love to hear from you.

Every application will receive a response.