Regulatory Affairs Specialist

Job Listing No: 9740000

Regulatory Affairs Specialist

CV-Library – United Kingdom – Galway – Regulatory Affairs Specialist Required for an innovative and award winning medical device manufacturer in Galway, Ireland. The job requires the person to work within the current Regulatory environment and complete a varied set of duties and responsibilities as outlined below Duties/Responsibilities: · In conjunction with Snr RA Specialist define regulatory strategy for individual products within the product development process. · Managing CE mark Submissions and Notified Body interactions as appropriate. · Assist Preparation of 510(k) regulatory filings & FDA correspondence on submissions · Managing Regulatory assessment of product changes and subsequent notifications to Regulatory agencies. · Work with distributors to ensure country specific registration activities are understood and appropriately addressed. · Participate in Notified Body / Regulatory Authority Audit preparation and follow up. · Identify and initiate action to address any adverse trends or regulatory compl… – Permanent – Full-time

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