Regulatory Affairs Ex. Medical Devices

Ref. no.: 102227

Tags: Regulatory Affairs Officer ISO13485 Regulatory Affairs Officer Regulatory Affairs Executive RA Officer

Location(s): Dublin City Centre Dublin North Dublin West

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 1 - 2 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Ciaran McArdle

Contact e-mail: dublin@brunel.ie

Job description:

Regulatory Affairs Officer (Medical Devices)

Market leaders in the distribution of pharmaceutical and diagnostic kits are currently seeking experienced applicants for Regulatory Affairs Officer (Medical Device Experience).

MAIN OBJECTIVES OF 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.

Ideal candidate will have a least two years experience working in a Regulatory Affairs department within a Medical Device organisation.

Excellent package on offer! Contact Ciaran McArdle for immediate interview dublin@brunel.ie +353 1 432 1510.