We are currently collaborating with our client, B. Braun, a world-leading healthcare supplier ranked in the Top 20 of Medical Devices Companies.
This is a hybrid role, with 2 days in our Dublin office and the remainder remote. This role reports to the Regulatory Affairs Manager.
Key Responsibilities:
* Support the Regulatory Affairs Manager in managing regulatory, compliance, pharmacovigilance & medicovigilance activities for products placed on the Irish market by BBMIRL.
* Manage product complaints from initial receipt through to closure, in conjunction with the company's Global Complaints Departments and relevant EU legislation, HPRA Guidelines and company procedures.
* Document and maintain complaint files for received reports.
* Promptly communicate complaints to the Global Complaints Department and escalate serious issues as necessary.
* Liaise with customers regarding product quality issues and medical/technical/clinical queries, ensuring accurate and prompt responses.
* Review product complaint investigation reports and document customer correspondence within required timeframes.
* Coordinate, implement and document product recalls, field safety corrective actions, quality defect investigations and compliance issues, liaising with relevant Global Safety/Vigilance Departments and the HPRA as required.
* Support Pharmacovigilance, Medicovigilance, Compliance and Regulatory Affairs activities as directed.
* Provide periodic training on product quality complaints, medicovigilance and pharmacovigilance to relevant personnel.
* Contribute to documenting and reviewing local procedures for product quality complaints, medicovigilance, pharmacovigilance and product recalls.
* Attend internal and external audits related to your job.
Additional Responsibilities:
* Fulfill additional administration and quality support as required.
* Back up other team members during annual or sick leave as needed.
Qualifications/Requirements:
1. A 3rd level qualification in a life science or pharmacy-related discipline.
2. At least 3 years' work experience in the Medical Device/Pharmaceutical Industry and a good understanding of GDP. Experience handling product complaints for medical devices and/or medicinal products is advantageous.
3. Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and the EU.
4. Proficiency in the English language; strong verbal and written communication skills are essential.
5. Ability to process technical information.
6. Accuracy and excellent attention to detail are key attributes along with strong organisational skills.
7. A proactive and collaborative work style and the ability to work with multiple priorities and deadlines.
8. Proven interpersonal skills and the ability to communicate with people at all levels within the organisation and externally.
9. Demonstrated ability to work both as part of a team and independently to determine priorities and achieve results.
10. Demonstrated ability to solve problems and drive task completion.
11. Proficiency in Microsoft Office required; experience with SAP is an advantage.