Technical File Assistant – Medical Devices

Our client, a rapidly growing medical organisation is currently looking for a Technical File Assistant to join their team in Wokingham.

This is an excellent opportunity to join a fast growing business in developing innovative products in an emerging market.

Key responsibilities

• Oversee the Design & Technical Documentation Files and ensure these are in accordance with key product requirements and safety standards as well as compliant according to European and Global regulatory measures
• Support the QA and regulatory affairs departments in the writing of technical documents as per the procedure and in line with ISO 13485
• Manage all necessary quality and regulatory documents needed for product registration submissions
• Ensure all processes and documentation are in line with quality and regulatory requirements as well as GMP and GDP practices
• Assist with any queries that may arise when developing quality and regulatory projects

Requirements

• Ideally, you will be educated to a degree level in a science discipline
• Previous experience in a similar role particularly within the medical devices industry
• Excellent knowledge of working under quality standards such as ISO 13485
• Great understanding of GMP and GDP requirements
• Thorough and multitasker individual with excellent attention to detail
• Excellent communication and organisational skills

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.