Regulatory Affairs Specialist:
Our client a leading Multinational Healthcare company now require a Regulatory Affairs Specialist
The Regulatory Affairs Specialist will help develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets, serves as a communication liaison between the my client local and international manufacturing facilities and the regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc) and associated correspondence to applicable Regulatory bodies.
The Regulatory Affairs Specialist will report to the Regulatory Affairs Manager, this is a permanent roles based in Munster.
Responsibilities for Regulatory Affairs Specialist:
- Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned.
- Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
- Responsibility for structuring and managing technical files.
- Plans and prepares regulatory submissions in the EMEA, and other markets as appropriate for new products, product changes and re-registrations as required.
- Responsibility for registration of all Class I devices with the Irish Medicines Board.
- Assess complaints from Cook global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.
- Utilize appropriate complaint software systems for processing complaints to/from distribution centres and QE Investigation functions.
- Generate appropriate regulatory reports based on assessment.
- Liaise effectively with regulators on all issues with regard to regulatory reporting.
- Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
- Communicate with other Cook Companies globally as necessary for reporting.
- Generate responses to inquiries on AE reports from various global regulatory authorities.
- Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
- Assist in coordination of Recall administration activities between manufacturer and distribution centre.
- Reviewing and approving reports and responses as necessary.
Requirements for Regulatory Affairs Specialist:
? Third level Qualification in Science/Engineering, at least 3 years? experience in a regulated industry in a similar role.
? Thorough knowledge of the EU, MDD requirements.
? Knowledge of requirements in GHTF countries.
? Desirable to have knowledge of requirements in other jurisdictions.
? Knowledge of medical device quality standards/practises or similar regulated industry.
? Approved External Auditor
Please send an up to date CV and cover note to John Reid at the RFT Group email@example.com / 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.