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Quality & Regulatory Officer


Escape Recruitment are excited to be working with a modern and innovative business within the medical device industry. Based in their Rosyth office, you will be an astute and talented Quality & Regulatory Officer with previous experience in either the medical device industry, or similar field. Providing breakthrough technology, this client is challenging innovation, and promote this ethos throughout their business as a forward thinking and adaptable organisation who are constantly revising and challenging boundaries in pursuit of excellence.

As the Quality & Regulatory Officer, you will be required to lead the company wide Quality Management system ensuring design specifications and standards are met. The role also has responsibility for regulatory clearance in target and existing markets, as well as providing technical support and guidance for product introductions, labelling and marketing claims, ensuring that quality standards are embedded throughout the organisation.

As Quality & Regulatory Officer you will be responsible for:

  • Administration of Quality Management Systems maintenance and improvement

  • Maintenance of ISO 13485:2016 and training on Quality Systems

  • Organise, respond, manage, and coordinate BSI audits and Internal Audits as well as coordinate and manage audit findings

  • Manage Document and Change Control Process and Review and Approval of documentation

  • Manage Supplier Approval and any Supplier Corrective Actions

  • Review and approval of all Validation Documentation

  • Maintain awareness of new proposed legislation applicable to our products, e.g., USA, EU, RoW

  • QC all medical device products which are newly manufactured

  • CAPA investigation and medical device release to market

We are looking for someone who has an entrepreneurial mindset with solid leadership and influencing skills, as well as being a versatile self-starter who requires limited supervision. 5+ year's experience in medical device manufacturing would be advantageous, as well as a relevant degree in Science or Engineering. Experience of international regulatory and quality processes including FDA, EU, and UK for Medical Devices is require as well as someone who is able to provide company wide guidance and support in Quality related matters.

If you would like to find out further information, please get in touch today.


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