Wondfo is a known Point of Care company with global reach, striving to improve the quality of life and human health by developing and improving invitro diagnostic tests. At Wondfo USA’s site in San Diego, you will be supporting in manufacturing diagnostics tests for the healthcare market. We are currently seeking a Clinical Regulatory Specialist II to fill an exciting position in our expanding R&D and Operation sites.
Responsible for the operational management of clinical studies, planning budget, set up, identification of applicable procedures and standards, and reporting of data.
Applies moderate knowledge of clinical study design and conduct of studies when interacting with external Clinical Research Organizations (CROs).
Maintains oversight, ensures study recruitment commitments are met, and pro-actively assesses and mitigates risks.
Supports the CRO for each clinical study in the timely preparation of required regulatory documentation, acquisition of required approvals, and initiation/set-up of study sites
Has working knowledge of local regulations and moderate knowledge of product development process, elements of design control, and applicable regulations and standards.
Reviews and provides input to product labeling and Health Risk Assessments/risk management activities.
Estimates resources required and ensures availability of required supplies and/or resources for clinical study activities.
Manages most activities without supervision. Interactions with supervisor involve periodic updates on activities, discussion of issues, proposals for resolution.
Possesses critical thinking and analytical skills and is capable of evaluating data to arrive at conclusions.
Identifies possible process improvement opportunities in own area of responsibility and works to implement them.
Asserts own ideas and fosters collaboration among team members.
May be asked to provide supporting data for a formal budget process.
Carries out tasks and activities that are defined by supervisor.
Bachelor’s degree in related field required.
Minimum three (3) years’ experience in Clinical/Regulatory Affairs or as a clinical project supervisor.
Experience with IVD clinical trials, in particular point of care (POC) and/or molecular diagnostics a plus.