Job Description:
As a 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.
You will ensure clinical data integrity, oversee clinical evaluations, and contribute clinical insights throughout the product lifecycle.
Key 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:
Qualifications:
* 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
Benefits:
The role provides remote working while also providing the opportunity to work on site if desired.