What are the responsibilities and job description for the Clinical Affairs Associate(IVD) position at TekWissen ®?
Position: Clinical Affairs Associate
Location: Fremont, CA
Duration: 12 Months
Job Type: Contract
Work Type: On Site
Shift: Monday to Friday 08:00 AM to 05:00 PM
Pay Rate: $30-39/Hourly/W2
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Summary
- This position is part of the Regulatory and Clinical Affairs organization.
- This position ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with applicable regulatory requirements (domestically and internationally).
What will you do?
- Drafting of Post Market Performance Follow Up Plans and Reports for Toxicology and Therapeutic Drug Monitoring Assays, and Clinical Chemistry Controls.
- Process change orders for approval of clinical documentation in electronic records management system.
- Assist in the preparation of additional Clinical Documents as needed, including but not limited to Clinical Performance Reports and Summary of Safety and Performance Reports.
- Organize, update, and maintain regulatory documentation in accordance with department and company procedures including maintaining logs and trackers.
- Maintain positive and cooperative communications and collaboration with Quality, Regulatory and Research and Development organizations.
- Perform other related duties and responsibilities, on occasion, as assigned.
Keys to Success:
- A bachelor’s degree with a preference for majors in Biological Sciences is required.
- Experience with an excellent understanding of EU IVD regulation (IVDR) a plus
- Must be able to write clear, understandable technical documentation
- Excellent attention to detail.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
Salary : $40
