|Location||New Jersey, United States|
|Sector||Pharmaceuticals & Biotechnology|
MDR/IVDR Clinical Compliance Specialist
Client is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
The candidate will be responsible for different tasks required to ensure implementation and gap assessment mitigation for clinical requirements related to the new IVDR/MDR compliance regulation. Upon successful implementation, the candidate will participate in ensuring maintenance of these records up to date as expected by regulatory agencies.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
The candidate will be responsible to:
• Provide relevant information to IVDR/MDR team. This includes but not limited to literature search, database mining, collating reports.
• Assess potential clinical study gaps existing against IVDR/MDR for the whole portfolio.
• Put mitigations in place to secure compliance, which may include clinical design development, literature search, etc.
• Execute mitigation plan with proper functions. This may include clinical study execution.
• Maintain Summary of Safety and Performance, Performance Evaluation Reports and Clinical Evaluation Reports and other relevant clinical documents and files for all regulatory agencies.
• Masters or Doctoral degree in Healthcare Science or related discipline, with a minimum of 5 years experience in clinical study/regulatory/research environment.
• At least 2 years of Medical Device medical writing experience (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).
• Experience of writing and reviewing CERs is mandatory
• Experience in the Medical Device/Diagnostics and/or Pharmaceutical Industry, preferably in the area of Diabetes and blood glucose measurement. Understand diagnosis and management of diabetes, possess knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).
• Possess knowledge of research methodology (including clinical investigation design and biostatistics);
• Proficient in information management (e.g. scientific background or librarianship qualification; experience with relevant databases such as Embase and Medline).
• Understand regulatory environment and requirement.
• Experienced in conducting clinical studies.
• Excellent personnel and project management, interpersonal, and organizational skills and business acumen are essential.
• Be able to gain understanding of the device technology and its application.