This role is for a subsidiary now based in the UK, focusing on the developing and manufacturing medical devices, looking to improve therapeutic drug monitoring. You will be part of an early stage but rapidly growing MedTech company operating at a senior level as the Quality Assurance and Regulatory Affairs Manager, aiming to be part of their success as they grow. You will be responsible for the Quality Management Systems (QMS) and regulatory obligations of the organisation and its products throughout the full product life cycle.
Quality Assurance and Regulatory Affairs Manager Responsibilities:
* Manage and review quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities
* Accountable for all Quality and Regulatory requirements for the business
* Accountable for internal and external audits
* Accountable creating and maintaining internal audit schedules and records including tracking CAPA activities as required
* Work closely with the technical and production team to improve production processes and quality control, in order to obtain CE mark
* Ensure that budgets and forecasts are developed, and actuals managed in line with corporate requirements
Quality Management and Regulatory Affairs Manager Requirements:
* Proficiency in quality systems (ISO 13485), associated documentation
* Proficient in medical device industry and medical device regulations (IVDD and IVDR)
* Risk management ISO 14971 experience
* Bachelor’s degree in a related field
* Minimum 5 years’ experience working in Quality and Regulatory roles within Medical devices
* Be passionate about technology, healthcare and entrepreneurship
* Be driven, motivated and organised
* Be an excellent written and oral communicator
* Be a team player with demonstrable leadership potential
* Be a quick learner willing to throw themselves into new challenges
As this company are ever growing, they are able to offer an attractive benefits package which includes contributory pension, competitive salary and a suitable holiday allowance.
If this role sounds appealing, please apply with an up to date CV.