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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Clinical Affairs Specialist (Remote)


Reference:SCA015363 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Senior Clinical Affairs Specialist (Remote)
Our medical device client are currently recruiting for a Senior Clinical Affairs Specialist to join their team on a permanent basis. As Senior Clinical Affairs Specialist you will be responsible for developing and executing global clinical strategies to support regulatory submissions, product approvals, and post-market evidence requirements. As Senior Clinical Affairs Specialist you will ensure clinical data integrity, oversee clinical evaluations, and contribute clinical insights throughout the product lifecycle. Experience with MDR and working with class III medical devices is an essential requirement. This role provides remote working while also providing the opportunity with work on site if you so wish.

Responsibilities

  • Develop clinical strategies and evidence plans for regulatory submissions and post-market requirements
  • Lead or contribute to clinical evaluations, literature reviews, data appraisal and analysis, and generation of clinical evidence reports
  • Serve as the clinical representative on product development teams and collaborate cross-functionally with regulatory, quality, and R&D groups
  • Prepare interim and final clinical reports, oversee investigator training, and support clinical trial monitoring
  • Provide clinical assessment for complaints, recalls, and other safety-related decisions
  • Engage with regulatory authorities to support approvals and respond to queries
  • Support clinical training initiatives and the development of advisory boards
  • Maintain compliance with relevant clinical, regulatory, quality, and safety standards
  • Manage clinical deliverables within defined timelines and budgets
Requirements
  • Degree in a scientific, engineering, health science or related field (or extensive relevant experience)
  • Recognised subject matter expertise with a minimum of five years of experience in the medical device industry
  • Experience with high-risk or implantable devices and global regulatory submissions
  • Proficiency in clinical evaluation methodologies, systematic literature reviews, and medical writing
  • Strong knowledge of medical device regulations (e.g., MDR 2017/745, FDA requirements) and associated guidance
  • Experience in clinical trial activities across feasibility, pivotal, and post-market stages
  • Ability to work independently and collaboratively within multidisciplinary teams
  • Experience interacting with clinicians and other healthcare professionals
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]