Clinical and regulatory affairs coordinator

Clinical and regulatory affairs coordinator

Position Summary:

We are seeking a detail-oriented and proactive Clinical and Regulatory Affairs Coordinator to support clinical trials for our IVD medical devices in the field of semen analysis. The hired person will assist in the planning, execution, and monitoring of clinical studies to ensure regulatory compliance and data integrity in alignment with Good Clinical Practice (GCP), ISO 13485, FDA, and IVDR requirements.

Key Responsibilities:

• Support the design and execution of clinical studies involving semen analysis IVDs, including CLIA-waived studies, method comparison, usability, and analytical performance trials.

• Assist in coordinating the IRB approval process: participate in protocol development, informed consent form drafting, and site training materials.

• Oversight of internal/ bench/ analytical performance studies.

• Clinical project management: monitor project goals and timelines.

• Analyze participants data (user questionnaires, demographics) and assist the study team in analyzing the study results and preparation of the study report.

• Maintain study documentation and clinical trial master files (TMF)

• Contribute to regulatory submissions: including FDA 510(k)/CLIA waiver applications and EU IVDR performance evaluation reports. Work with the regulatory team with preparation of scientific and literature reviews as part of regulatory submissions

• Responsible for updating clinical aspects of regulatory files: Shelf life studies, PMS (Post Market Surveillance) reports, clinical evaluation report

Requirements and Qualifications:

• Bachelor's degree or higher in life sciences, medical technology, biomedical engineering, or a related field.

• Minimum 2 years of experience in clinical research and/ or in regulatory affairs, preferably in IVDs or medical devices;

• Familiarity with GCP, ISO 13485, FDA regulations (21 CFR Part 812), and IVDR requirements for performance evaluation studies.

• Understanding of laboratory workflows.

• Excellent organizational, interpersonal, and communication skills.

• Ability to manage multiple tasks simultaneously.

• Proficient in Microsoft Office.

• Fluent English speaker and excellent writing skills.