£50k per year
8 months ago
My client, a successful leading global provider of medical devices based in South London, is looking for an experienced Quality and Regulatory Affairs Manager to lead and manage all aspects of the QARA function in relation to products, processes and customer satisfaction.
Title: Quality and Regulatory Affairs Manager
Type: Medical Devices
Location: South London
- Plan and prepare regulatory submission documents for regulatory filings for all medical devices Worldwide.
- Provide regulatory guidance throughout product development, from design development and manufacturing of new products
- Support the CE Marking and submission process for Global competent authorities
- Strategic management and implementation process to manage post market surveillance activities
- Pro active management of vigilance and incident report processes
- Ensure compliance with EU Directive 93/42/EEC (as amended) and (EU) 2017/745 MDR
- Implement and maintain an ISO13485:2016 compliant QMS
- Participate in internal and external audits
- Promote a culture of compliance to regulations, standards, procedures and risk management
- Management of a small team
- Bachelor degree or equivalent in engineering or science of business related field
- At least 5 years’ experience within the Medical Devices industry working within an ISO 13485 environment (Class iib)
- Working knowledge of Global Medical Device regulations and quality standards, e.g. ISO 13485
- Experience of working directly with competent authorities and Notified Bodies
- Experience with active medical devices
- Experience with use of quality tools and root cause investigation methodologies
- Experience managing a small team
- Ability to communicate at all levels and successfully influences individuals, including external stakeholders.
If you are interested in this position and your experience meets the below requirements, please apply via the button below. If you do not receive a response on your application in 3-5 working days, please assume your application has been unsuccessful on this occasion.
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Catalyst Life Sciences
Catalyst Life Sciences is a recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;
- Pharmacovigilance/Drug Safety
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Medical Information
- Medical Writers
- Medical Affairs
- Clinical Trials
- Clinical Research
- Project Management