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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Senior Regulatory Affairs Specialist


Reference:JCAO3103 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Senior Regulatory Affairs Officer

Our client a medical device start up are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approvals. This position can be fully remote.


Role/Responsibilities

  • Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy.
  • Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
  • Support the creation and maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices).
  • Assess and support design and process changes with cross-functional team members, ensuring completion of all associated regulatory activities.
  • Keep up to date with changes in applicable regulatory requirements and standards, and where appropriate coordinate and/or conduct gap assessment activities.
  • Participate in discussions with regulatory authorities.
  • Assist company preparation for inspection by notified body and regulatory authorities.
  • Support implementation and continuous improvement of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
  • Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training.
  • Ensure interactions with colleagues/stakeholders fully reflects the company values:
  • One Team: working together to ensure the whole is greater than the sum of the parts
  • Personal Ownership: deliver on commitments
  • Open Communication: Honest open-minded communication
  • Fun: celebrate the successes
  • Continuous Learning: at an individual and company level
  • Solution Orientated: Identify problems but focus your energy on solutions
  • Quality Focused: patient safety comes first
Skills/Experience
  • Bachelor’s or master’s degree in science or related disciplines
  • Minimum of five (5) years of related experience in Regulatory Affairs
  • Experience preparing technical documentation for submission to regulatory agencies
  • Class III medical device experience preferred
  • Clinical trial experience preferred
  • Working knowledge of GMP, FDA QSR and ISO 13485 requirements
  • Excellent communication, organisational and time management skills
  • Availability to travel is required
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322