Regulatory Affairs Manager

Warwickshire | Design, Engineering

Regulatory Affairs Manager - Medical Device - West Midlands - £50,000 - £55,000 + BenefitsSRG are currently recruiting for a Regulatory Affairs Manager to join a SME Medical Device company in the West Midlands on a permanent basis at a salary of £50-55k + Benefits.You will be responsible for supporting the company's regulatory function by assisting in the completion of the company's filings for key global territories and also supporting customer's regulatory efforts. This role reports directly in to the Director of QA/RA and has line management responsibilities for a Junior RA Officer.Responsibilities;* Lead the preparation of global regulatory strategies to support the registration of new and modified products.* To drive development and execution of all regulatory filings working closely with the New Product Development, Quality Assurance and Operations teams. Such filings will include 510(k) submissions and CE Mark Technical Files and Design Dossiers.* In association with the Commercial function, interface with our customers to support their regulatory strategies and compliance.* Manage communication with Regulatory Authorities and Notified Bodies to address RA questions and submission issues.* Compliance responsibilities: With the Director of Quality / RA, The management of global regulatory strategies to support the registration of new and modified products and to implement the regulatory project plan including applicable regulatory submission schedule deliverables.Key Skills & Abilities * Experience within Regulatory Affairs within a Medical Device company.* Able to demonstrate a broad understanding of medical devices and regulatory affairs* Able to get on with and influence people both internally and externally to achieve objectives.* Able to work with minimum supervision and as a part of a team* Strong communication skills, flexible attitude and capable of working to tight deadlines under pressureFor more information, please call Laith Mustafa on or email

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Contract Type
Expiry Date
26/10/2019 22:45:00
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