Regulatory Compliance Lead

Location: Waterford, Republic of Ireland Salary:
Sector: Quality Assurance (QA) Type: Permanent

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.

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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales