Senior Regulatory Affairs Specialist

Galway  ‐ Onsite
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Description

The Regulatory Affairs Specialist must be a talented and highly motivated individual. The position will participate in quality audits and support on-going compliance in the product development process. The position will be responsible for the preparation of documents for submission to regulatory bodies (ISO Notified Body, FDA, etc.) for various Medical Device products as well as support other functions in the area of Regulatory Submissions.
Responsibilities:
Participate in the review and approval of document change orders
Assisting with the administration of internal auditing and third-party inspections
Review, evaluate and compile files and reports in preparation for U.S. and international regulatory submissions
Participate in the complaint handling process
Identify and report critical regulatory/compliance issues
Maintain a system for the periodic review of new or revised regulatory changes
Responsible for internal regulatory file documentation
Prepare and maintain annual regulatory reporting
Skills and Experience:
Bachelor's Degree or higher in Life Science or related discipline. Professional certification(s) required.
3-5+ years of experience in Regulatory Affairs for the Medical Device industry
Considerable experience with relevant FDA, QSR, ISO standards and MDD
510(k) submissions and technical file experience a must
Familiarity with ISO 60601 desirable
Excellent written and oral communications, strong interpersonal and influencing skills are required.
Start date
04/2015
Duration
6 months
From
Real Staffing
Published at
01.04.2015
Project ID:
877783
Contract type
Freelance
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