A Quality and Regulatory Affairs Manager is required for a South London based business paying up to £55,000 plus bonus, pension, and other good benefits. You will bring your knowledge of Medical Devices and ISO 13845 to the growing and successful Life Science business.
Due to the nature of the business, the emphasis of your workload will be on Regulatory Affairs, but you will also manage the QA functions.
Your duties will include:
• Plan and prepare regulatory submission documents for all medical devices on a global basis
• Provide regulatory guidance throughout the lifecycle of the product from development, design and in the manufacturing stage
• Support the CE Marking and submission process for Global competent authorities
• Proactive management of incident report processes
• Ensure compliance with EU Directive 93/42/EEC and (EU) 2017/745 MDR
• Implement and maintain an ISO13485:2016 compliant QMS
• Participate in internal and external audits
• Promote a culture of regulation, standards, procedures and risk management
Experience of working in the Medical Device sector is a must with a comprehensive knowledge of an ISO 13845 environment. A methodical approach who is able to prioritise requirements and deliver results in this important and highly valued department is a must.
If you are looking to step up into a management role or are currently in a supervisory or management position in the Quality and/or Regulatory environment, contact Senex Recruitment to discuss this opportunity.
As a minimum, you will have a degree in a related STEM subject, with working experience with competent authorities and Notified bodies. Experience with the use of quality tools and root cause investigation methodologies would be highly suitable.
If you are ready for the challenge offered by this well respected Medical Device company contact Kevin McHugh on 01424 211872 or email your CV to email@example.com
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