Global Medical Device Clinical Regulatory Specialist

1 day ago

Dublin, Dublin City, Ireland beBeeClinical Full time €120,000 - €140,000
Job Title

Clinical Regulatory Specialist - Global Opportunities

Job Description

This role offers a chance to work on the development of pioneering structural heart devices through design, verification, clinical trials, validation, and regulatory approval.

Key Responsibilities
  • Coordinate global clinical trial execution, including site activation, enrolment, follow up and closure, in accordance with the study schedule.
  • Communicate study status and timelines, escalating unresolved issues to line manager as necessary.
  • Support the development of study documents, including protocols and Investigator's Brochure, and regulatory submission deliverables.
  • Maintain the clinical study electronic database and ensure accurate information is readily available.
  • Oversee clinical product inventory and ensure timely supply of materials to clinical sites.
  • Manage essential documents and Trial Master File, ensuring inspection-readiness and identifying opportunities for continuous improvement.
Regulatory Responsibilities
  • Ensure compliance with internal and external regulatory requirements.
  • Review and assess changes affecting clinical investigations, working with cross-functional teams.
  • Prepare regulatory submissions for clinical and commercial applications.
  • Interpret new or revised medical device regulations and develop internal procedures to ensure compliance.
Required Skills and Qualifications
  • Technical knowledge: quality principles for medical devices, Good Clinical Practice and Regulatory standards.
  • Problem-solving skills: data-driven approach to ensure high-quality devices.
  • Project management and organisational skills: ability to complete tasks on time.
  • Initiative: prioritise work, reach business objectives and challenge task team decisions as required.
  • People skills: work effectively with others to achieve company goals.
  • Communication skills: effective technical communication and presentation skills.
Essential Requirements
  • Science or engineering degree or master's degree.
  • Experience in medical device Clinical Affairs or Regulatory Affairs preferred.
  • Class III medical product development experience preferred.
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements preferred.

Availability to travel is required. This role profile is not comprehensive and duties may change over time.

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