Manager of Quality & Regulatory (QA/RA) - Biomedical

Description

Manager of Quality & Regulatory (QA/RA) - Biomedical
Salary Discussed Upon Application - £/GBP
Permanent
SE England

Optimus Life Sciences are working with a very interesting Bio-medical start-up based in the South West of England, they are looking for an experienced Quality Assurance and Regulatory Affairs Manager to join them in a long-term role.

The company are looking to develop the capabilities of innovative technology, working alongside a very talented R&D department to expand an already developed portfolio. The role underpins the company's plans for growth; focusing on identifying and addressing current and potential challenges to the companies QA and RA procedures.

This role requires applicants who're looking at the 'bigger picture', initially the position will require you be hands on and have a working input into a variety of aspects of the QMS and Regulatory understanding. In time, the role will develop into more of a managerial and oversight position working either at one of the manufacturing sites or the company's HQ.

Requirements

• Developed (and practical) understanding of Quality Management Systems and the process for Regulatory Approval of innovative medical products.
• Experience working on the full-life cycle of product development and release, from a QA/RA perspective. You will be involved from development to manufacturing to approval to launch.
• Ability to work collaboratively with colleagues, implementing and training company initiatives within the Quality and Regulatory landscape.
• Proactive approach to solving issues, with a track record of doing so.
• Strong knowledge of ISO 9001 and GMP requirements.
• Flexibility.
• Preferably would have worked within a number of different product types in a similar position.

This is an interesting role and a great opportunity. There is no doubt that this may be a challenging role, but for the right type of person this is a really good chance to join an already strong - and growing - company with grand plans for the future.

I am able to provide more information on application, so if you think this may be a good opportunity for you; please send over a CV to and we can talk in more detail.