- Reference: CJ44804y
- Job Type: Permanent
- Location: Munster, Waterford
- Category: Science, Pharmaceutical & Food
The regulatory affairs specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation.
1. Ensure continuous compliance with the following:
- FDA Quality System Regulation 21 CFR 820 (QSR)
- Medical Device Directive
- Health Canada Medical Device Regulations
- ISO13485 Medical Device Quality Management System
- Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
- All Internal Procedures
2. Assist with regulatory submissions within:
- European Union (Class IIa, Class III)
- United States (Class II, 510k
- Annual reports
- Supplements and registrations
3. Assist with preparation and closing activities associated with:
- United States FDA inspections
- ISO 13485 audits
- Other Regulatory Agency Audits
- Internal audits (see appendix 1 for details)
4. Process customer notification and regulatory requests
5. Support Quality system and regulatory system improvements activities
6. Support, Maintain and Develop document control system through
- Regular audits of the scanned DMR
- Ensuring timely and accurate processing of ECOs and rework requests
- Providing administrative support to Quality Dept.
- Ensuring upkeep of Archives
- Control master labels
- Issuance of Document system reports
- Ensuring effective resolution of Document system queries or requests
- Liaising with Chaska Regulatory Affairs department for all the above where required.
7. The Regulatory Specialist will provide support in the following:
- Planning and Communication with Regulatory contact
- Internal Planning and Communication & document co-ordination
- Audit assistance for duration of audit
- Communication & Feedback afterwards
- Co-ordination of corrective action and response issuance
- Training of internal personnel on audit techniques
- Update of related slides for KPI
- Assistance with completion of annual schedule
- Review of audit reports and other documentation to ensure compliance to procedure
- Carry out internal audits as per schedule
- Drive improvements in Internal audit process and prepping auditors
- Maintain of Internal audit documentation
- Communication internally- Quarterly meetings and Plant KPI
Customer and Regulatory Support
- Completion of customer surveys and questionnaires in a timely fashion
- Management of regulatory documents e.g. requested certs of free sale, apostilled certs
- Keeping up to date with regulatory affairs as they affect LRI-changes to QA policy, Manual etc
- Keeping up to date with current Regulatory requirements for e.g. FDA, E.U., Japan
- Ensuring that the external standard documents as per master list are current
- Supporting Regulatory related projects e.g. Design & Development scope addition for the company.
- Carry out Regulatory audits to ensure fulfilment of requirement for Design and Development scope
- Update of procedures related to Regulatory requirements
Document Control Support
- Assistance with management of issues and queries as they arise
- Ensure Doc requests are addressed in a timely manner
- Assisting with organization of work load of team based on priorities
- Document Control meeting co-ordination
- Ensure files and folders related to Doc control are maintained
- Support improvement projects- JDE implementation
- SME for JDE system
- Input to RCAs related to Doc Control.
- Co-ordination of RCAs for indirect depts.
- Input to reports required for Quality -Quality Quarterly report.
- Ensure that KPI boards are update
- Ensure that weekly & monthly reports e.g. Scanning audit, ECO report, Weekly overdue document report & Overdue RCA report are issued on time and per procedure
- Co-ordination of training for new employees to Document Control
- Ensuring that Document Control related audits are carried out per procedure e.g. KPI board
Qualifications and Experience
- College graduate with Engineering or science degree or equivalent experience.
- Qualified systems lead auditor an advantage
- 1-3 years’ experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
- Ability to communicate and work with people inside and outside the department.
- Ability to co-ordinate, plan and organise
- Rigorous attention to detail.
- Excellent attention to detail and organisation skills.
- Ability to work to deadlines and on own initiative.
- Excellent interpersonal skills
- Excellent verbal and written communication skills.
- Working knowledge of Excel and Word.
- Experience with USA regulatory requirements would be advantageous.
For a confidential discussion and more information on the role, please contact Aisling Lane on 021 4809118 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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