Responsibilities
- Key member of the Quality Systems Team contributing to the overall success and direction of the Quality Operations Department.
- Act as the main point of contact for all regulatory affairs requests, providing timely and accurate information to internal and external stakeholders.
- Maintain logs of Annual Reportable Changes
- Complete Review and Approval of Annual Reports.
- Coordinate and manage completion of gap assessments of updated MDGP documents and Regulatory Guidance Documents cross functionally.
- Conduct comprehensive regulatory assessments to ensure compliance with applicable regulations and standards.
- Maintain up-to-date knowledge of regulatory requirements and industry standards.
- Prepare and submit regulatory documentation to relevant authorities such as HPRA.
- Monitor and track regulatory changes and communicate their impact to the relevant departments.
- Administer and manage activities related to the Electronic Learning Management System (ELMS), including user access, content updates, and system maintenance.
- Investigate and document Quality Assurance related deviations and escalate issues as appropriate to the Quality Systems Leader in a timely manner.
- Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
- Participate and support site audits as required
- Raise and lead change controls as required.
- Complete additional activities as required and dependent on business needs
- Suggest improvements and conduct continuous improvement activities.
- Assure site and business is properly prepared for external and internal compliance inspections by having results from their inspections be non-systemic and without warning letters. Collaborate closely with business partners to ensure site is audit ready at all times
Key member of the Quality Systems Team contributing to the overall success and direction of the Quality Operations Department.
Act as the main point of contact for all regulatory affairs requests, providing timely and accurate information to internal and external stakeholders.
Maintain logs of Annual Reportable Changes
Complete Review and Approval of Annual Reports.
Coordinate and manage completion of gap assessments of updated MDGP documents and Regulatory Guidance Documents cross functionally.
Conduct comprehensive regulatory assessments to ensure compliance with applicable regulations and standards.
Maintain up-to-date knowledge of regulatory requirements and industry standards.
Prepare and submit regulatory documentation to relevant authorities such as HPRA.
Monitor and track regulatory changes and communicate their impact to the relevant departments.
Administer and manage activities related to the Electronic Learning Management System (ELMS), including user access, content updates, and system maintenance.
Investigate and document Quality Assurance related deviations and escalate issues as appropriate to the Quality Systems Leader in a timely manner.
Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.
Participate and support site audits as required
Raise and lead change controls as required.
Complete additional activities as required and dependent on business needs
Suggest improvements and conduct continuous improvement activities.
Assure site and business is properly prepared for external and internal compliance inspections by having results from their inspections be non-systemic and without warning letters. Collaborate closely with business partners to ensure site is audit ready at all times
Qualifications and Requirements
- You have achieved at least a Professional Level 8 degree qualification in Science / Engineering discipline or equivalent knowledge or experience.
- You have previous experience in a QA Specialist Role or equivalent.
- You have previous experience with Regulatory Affairs and Regulatory Compliance.
- You are a proactive planner, and an effective communicator.
- You have some experience in working, developing strong working relationships and influencing cross-functionally.
- You have experience working with ComplianceWire, Veeva and Trackwise or equivalent.
- Excellent organisational and project management skills.
- Strong attention to detail and ability to work independently.
You have achieved at least a Professional Level 8 degree qualification in Science / Engineering discipline or equivalent knowledge or experience.
You have previous experience in a QA Specialist Role or equivalent.
You have previous experience with Regulatory Affairs and Regulatory Compliance.
You are a proactive planner, and an effective communicator.
You have some experience in working, developing strong working relationships and influencing cross-functionally.
You have experience working with ComplianceWire, Veeva and Trackwise or equivalent.
Excellent organisational and project management skills.
Strong attention to detail and ability to work independently.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Relocation Assistance Provided: No