SNR REGULATORY AFFAIRS SPECIALISTROSCOMMON

back to search results
  • Job reference number:15450427
  • Client ID:RI/BBBH2277
  • Posted on:10-JUN-2019
  • Salary:NEGOTIABLE
  • Location:ROSCOMMON, ROSCOMMON
  • Job type:PERMANENT

Benefits: PENSION / PRSA

Senior Regulatory Affairs Specialist


Responsibilities:

A great opportunity to join a well established company where you would be contributing to impoving the lives of others as well as enjoying a great culture and work life balance.

  • Dev. of data for EU MDD Class III Design for submission to maintain CE Technical Files aligned with device & process changes.
  • Interpret new Medical Device Regulations & develop internal procedures to ensure compliance with all reg. requirements
  • Support reviews of Change Request impact on reg. filings, & update latter where applicable
  • Key member of the NPI , design control teams & site eng. projects to ensure device compliance to appropriate International Reg. requirements.
  • Integral part of the Risk Mgt. team, supports maintenance of Risk Mgt. Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device & process changes.
  • Support comms between eng depart. & third party electrical safety certifiers
  • Support assessment & closure of audit findings & related to reg. / QMS audits as needed.
  • Assist QA in CAPA investigation & root cause analysis, & performance of effectiveness activities.
  • Support dev. of reg. strategy for & execution of transition from the Medical Device Directive to the Medical Device Regulation.


Qualifications:

  • Third level qualification in an engineering or science discipline.
  • At least 5 years' exp. in a RA role, or equivalent medical device (i.e. quality, engineering, etc.) within a CE marking, FDA & ISO 13485 regulated medical device .
  • Exp. of EU Medical Device Directive, 21CFR820, 803 & 807, & ISO 13485 requirements
  • Exp. in internal audit ing for compliance to Medical Device QSRs is not required, but is an advantage
  • Great communication skills with mgt. & fellow peers, both in person & remotely
Please apply for a confidential discussion with Nicola

This job originally appeared on RecruitIreland.com