Senior Regulatory Officer
at QA RESOURCES
Limerick, County Limerick, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 02 Aug, 2024 | Not Specified | 06 May, 2024 | 5 year(s) or above | Good communication skills | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
ROLE SUMMARY – MAJOR ACTIVITIES:
- Provide coaching and support to all employees on the regulatory team.
- Ensure employees understand their duties/delegated tasks.
- Prepare and maintain IVDR compliant technical files utilising information from cross functional teams for IVD Products (Class A – D).
- Assist in IVDR projects, representing Regulatory Team on cross-functional team.
- Represent the regulatory team on all new product development and change controls to ensure device is compliant to appropriate regulatory requirements.
- Review all project documentation across multiple projects and final sign off as regulatory representative.
- Ensure all deadlines are on target/met.
- Track and control all regulatory submissions for product changes or renewals for device certification.
- Coordination of risk management activities and documentation for CE-IVD marked products.
- Approve all labelling (labels, instructions for use) for compliance with applicable regulatory requirements and international standards, including UDI.
- Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), procedures etc.
- Review complaints for regulatory reporting for CE-IVD marked products.
- Prepare reports for Regulatory Manager/Senior Management as required.
KEY COMPETENCIES OF ROLE:
BSc in science/molecular biology or related discipline.
3 – 5 years’ experience working in a Medical Device or In Vitro Diagnostic Company.
Excellent communication and interpersonal skills.
Ability to manage competing priorities in a fast-paced environment.
Strict attention to detail.
Ability to work to tight deadlines.
Location: Limerick (Hybrid Working arrangement)
Contractor Duration: Full time permanent rol
REQUIREMENT SUMMARY
Min:5.0Max:10.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
BSc
Biology
Proficient
1
Limerick, County Limerick, Ireland