£ CompetitiveThis is an exciting new opportunity to work for a unique and well-funded start-up biotech company based in Cambridge, specialising in point of care diagnostic discovery which is at the point of international commercialisation.
You will use your well-developed quality and regulatory experience to inform the inception of the QMS, and be on hand to answer both internal and external queries relating to the quality and regulatory requirements of a thriving new business. Role requirements:
* Development of the QMS from scratch, to take into account the requirements of ISO 13485 and the requirements for swift technology development and scale-up
* Expanding the QMS to assist the manufacturing teams of life scientists creating POC products, and the input for documentation for regulatory submission
* Working in a highly commercial and fast-paced environment with multiple stakeholders
* Able to communicate effectively, taking into account the quality and regulatory perspectives for a wide range of scientists, operations and sales peoplePerson specification:
* BSc or MSc in a Life Science or related discipline
* Demonstrable background working with ISO 13485 QMS within a pharma, biotech or medtech organisation
* Proven track record in making a significant contribution to the design, implementation and maintenance of an ISO 13485 QMS
* Your background will also highlight experience within R&D, ideally from a minimum of two ISO 13485 accredited environments
* Curious by nature, excellent written and verbal communication skills, strong eye for detail and solutions-focused.
If this describes you and your next move then please contact Bec Johnston: email@example.com / 01223 607858