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DATE ADDED: Wed 06/11/2019

QARA Manager

Croydon, UK
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JOB TYPE: Permanent

QA/RA Manager- South London- Perm - Medical Devices

Looking for a new challenge within the Medical Device Industry? Experienced managing a teams?
If you have an in-depth understanding of the national, regional and international QMS and regulatory requirements for medical devices then we have the role for you. Based in South London you will be managing a team of 7 QA and RA Engineers.
You will be leading, managing and developing both teams and overseeing interdisciplinary projects. The main responsibilities are to prepare and manage the submissions and the approval process for regulatory filings, CE Mark Technical files and Design Dossiers across several international markets, as well as managing the eQMS, overseeing the of drafting of documentation, CAPA and NCR to ISO13485.
Experience with Vigilance reporting and an ISO 13485 Lead Auditor Qualification would be an advantage.
If you have several years' Quality and Regulatory experience within ISO 13485 (Ideally Class II) across a range of international markets, have managed a small team before and have worked directly with competent authorities and Notified Bodies then get in touch for a fully confidential talk on (phone number removed)
Role: QARA Manager
Job Type: Permanent
Location: Croydon, Greater London,

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