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Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Location: Galway
Industry:
REF: 88739
Job Published: 7 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Regulatory Affairs Specialist
Our client, a medical device company in Galway are currently looking to recruit a Regulatory Affairs Specialist for their site on a contract basis.


Main Duties/Responsibilities:
  • Assist with determination of global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
  • Participates on various teams to define regulatory requirements for EU, U.S. and international submissions.
  • Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
  • Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
  • Interacts with various levels of management, external agencies and companies.
  • Assists with analysis and making recommendations regarding complaints received by the company and whether they are MDR, MPR or Vigilance reportable; participates in complaint related meetings.
  • Assist with developing, maintaining and analysing department systems and provides training when needed.
  • Remains current on developing regulations and revises systems as necessary.
  • Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
  • Performs other related duties and tasks, as required.


Minimum Qualifications/Competencies:
  • Education and experience equivalent to a Bachelor's Degree in the biological, physical, engineering or material science disciplines and four years of related experience.
  • Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards.
  • Self-motivated, self-directing, strong attention to detail and excellent time management skills.
  • Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.
  • Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
For further information on this Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 091730022 / bimi@hero.ie
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