I currently have an opening for a Regulatory compliance Lead in a leading medical device company located in Waterford.This is an exciting role with great opportunities for progression.This company has been in Waterford for almost 40 years and currently expanding.
What I will be doing as a Regulatory Compliance Lead ?
- Manage external standards compliance for the business.
- Drive alignment and harmonization of external standards within the business and initiate activities to ensure compliance.
- Coordinate participation in industry associations and standards working groups e.g. ISO.
- Provide expertise in areas of interpretation wrt MDD 93/42/EEC, EU 2017/745, ISO 13485 & QSR.
- Provide expertise in regards to implementation of EU MDR 2017/745 and contribute to discussions internally and with Notified Body.
- Provide support to the Brexit and MDR projects and ensure risks are assessed and mitigated.
- Support EU MDR work streams e.g. economic operators, technical documentation, quality systems.
- Partner with regulatory affairs in regards to new product submissions.
- Support audits & inspections (Notified Body & FDA) of manufacturers, importers and distributors.
- Provide regulatory compliance support to the businesses manufacturing sites and EU Authorised Representative.
- Deputise for the Regulatory Compliance manager as required.
- Field questions from competent authorities in regards to product performance and/or vigilance on the EU market.
- Participate in local industry outreach activities in Ireland e.g. HPRA meetings, NSAI, IMDA etc
- Attend key trade association meetings and conferences.
What I need to be a Regulatory Compliance Lead ?
- Bachelor's Degree BSc in an engineering or scientific discipline (Chemistry, Biology, Microbiology, Pharmacy or related technical field).
- Experience in Regulatory Compliance, Regulatory Affairs or Quality Systems is desired.
If you are interested in hearing more about this opportunity with a leading company going through an exciting growth phase please respond with an updated CV.
To find out more about Real please visit www.realstaffing.com
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