Ref. no.: MK/38460/IJP
Tags: Regulatory Affairs Officer Dublin Regulatory Affairs Specialist Regulatory Affairs Regulatory Affairs Officer Dublin North
Location(s): Dublin North
Salary range (€): Negotiable
Additional benefits:
Minimum experience required: 3 - 4 Years
Employment type: Permanent Full-time
Minimum qualification: Third Level Degree
Contact person: Michelle Kilcar
Contact e-mail: michelle@ccprecruit.ie
Job description: Regulatory Affairs Officer Main Objectives of the job: · To ensure compliance with IVD and MDD directives & other regulatory requirements · To assist QA Manager in any area of quality or regulatory affairs Main Duties & Responsibilities: · Review and Update of technical files and dossier · Apprise company of developments in national and EU regulations and legislation · Coordinate complaint investigations, follow up corrective actions, respond to complainant and prepare periodic summary reports. · Assist with CE marking of products · Coordinate audit programme and carry out internal and external audits · Ensure product registrations are current and compliant · Initiate corrections to Master Documents & Procedures as required · Communicate with local and international regulatory authorities regarding licence applications, vigilance and compliance issues · Liaise with & provide support to local companies on regulatory and quality issues · Collect data and write reports for projects/assignments as indicated by the QA Manager · Maintain ISO 9001 and 13485 Quality System · Assist in resolutions of quality issues that arise at sub contractor level · Approve regulatory aspects of artwork · Assess sub contractors to ensure they comply with release requirements · Collect post market surveillance information · Carry out other related duties as required. · Assist in resolutions of quality issues that arise at sub contractor level · Approve regulatory aspects of artwork · Assess sub contractors to ensure they comply with release requirements · Collect post market surveillance information · Carry out other related duties as required.