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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Principal Regulatory Lead


Reference:JCAO0812 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs



Our client a Galway based Medical Device company currently seeking a Principal Regulatory Affairs Lead to join their team. Reporting to Director of Regulatory Affairs the Principal Regulatory Affairs Lead will help lead Regulatory strategy and engage with key Regulatory Bodies to support these projects


Role/Responsibilities

  • Lead compilation of international regulatory submissions for products under development.
  • Manage regulatory submission timelines, identify risks and appropriate mitigations.
  • Review the data intended for submission in international regulatory applications. Identify gaps and make recommendations.
  • Participate in risk management activities for designated projects.
  • Provide regulatory input during design control process to development projects.
  • Support CE Mark maintenance and substantial change submissions to notified body.
  • Define and capture the regulatory strategy for the development project(s).
  • Co-ordinate and support regulatory reviews and meetings with EU Notified Bodies, Competent Authorities, FDA, PMDA and NMPA.
  • Review and contribute to regulatory aspects of change control, non-conforming process, labelling changes etc.
  • Support routine safety reporting activities for clinical investigations.
  • Support vigilance reporting activities.
  • Support post market surveillance reporting, annual progress reports.
  • Review and contribute to clinical evaluation reporting activities.
  • Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, MDR 2017/745, FDA Quality System Regulations 21 CFR Part 820 ,ISO 14971, and Japanese Ministerial Ordinance #169.
  • Work towards achieving compliance to the Medical Device Regulation 2017/745.



Skills/Experience
  • Degree level qualification in engineering or a strongly related field.
  • A minimum of 5 years’ relevant regulatory experience in a senior regulatory role in the medical device or pharmaceutical industry, ideally with Class IIb and Class III medical devices.
  • Technical competency of ISO13485:2016, MDD 93/42/EEC, MDR 2017/745, and the FDA QSRs is a prerequisite.
  • Good communication and organizational skills, computer literacy and the ability to present reports neatly and accurately is essential.

To findout more please contact James Cassidy [email protected] or call in confidence 0860204322