Regulatory Affairs Specialist with 7+ years experience required for a permanent role with a medical device company in Co. Limerick. 

Responsibilities:

  • Develops regulatory strategies and provides guidance and expertise.
  • Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
  • Reviews and approves the project documentation (design reports, labelling, etc.).
  • Ensures that updates to the Technical Files and international registrations are conducted appropriately.
  • Develops tactics supporting first to market commercial opportunities, and minimizes time to product launch.
  • Works closely with the other functions (QA, R&D, Medical Affairs…) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
  • Identifies roadblocks, defines problems based on data / facts and effectively communicates with his/her peers, project teams or management (as appropriate) for seeking solutions.
  • Supports continuous improvements in regulatory processes, QMS processes or company-wide initiatives.

Requirements:

  • B.Sc. in Electronics or Biomedical engineering discipline
  • 7+ years’ experience in Regulatory Affairs within medical devices industry with exposure to programmable electrical equipment. Alternatively a strong technical experience in the field of Programmable Electrical Medical systems including exposure to regulatory affairs requirements
  • Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…)
  • Knowledge of software, instrument and disposable design practices
  • Experience with representing Regulatory Affairs in multiple environments
  • Strong analytical and planning skills, with the ability to make decisions and to translate those decisions into actions
  • Strong communication and negotiation skills
  • Ability to work in a multicultural environment
  • Ability to detect opportunities for improvement and develop and implement plans
  • Strong attention to detail
  • Must be authorised to work in Ireland & available to travel (EU and outside EU) 
  • Knowledge of FDA regulatory requirements is a plus

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

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