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Senior Clinical Affairs Specialist

Company Name: Hycor Biomedical
Location: Garden Grove, CA
Job Type: Full-time
Contact Name: Lizelle Cristobal
Phone: 
Fax:
Email:  This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: DOE

Job Description

Hycor Biomedical is seeking a Senior Clinical Affairs Specialist to plan, coordinate, and execute clinical performance studies in support of product development, FDA submissions, EU technical files, other global submissions, and post-market goals. 

The Senior Clinical Affairs Specialist has a leading role in the planning, coordination, and execution of Hycor’s clinical performance studies.  She/he must have excellent verbal and written communication skills, have the ability to motivate and manage teams and have in vitro diagnostic (IVD) technical clinical research operational skills. The Senior Clinical Affairs Specialist must have an excellent working knowledge of applicable regulations and guidelines.

Job Requirements 

  • Minimum of 7 years of experience in diagnostics, life science, or medical devices with a minimum of 5 years in clinical research and 2 years of IVD specific clinical research.  IVD assay development experience is a plus.
  • Demonstrated ability to successfully manage and execute clinical studies with IVDs to meet business goals using standard best practices and compliance norms.
  • Demonstrated ability to supervise CRAs and Monitors, and work successfully on cross-functional teams.
  • Detailed knowledge of GCPs, ISO 14155, and EN 13612.
  • Working knowledge of IDEs, 510(k)s, and IVDD/IVDR.
  • Working knowledge of ISO 13485, Quality System Regulation, and relevant international standards.
  • Working knowledge of medical device risk management standards and guidance documents, specifically ISO 14971.
  • Proven track record of maintaining clinical knowledge and skills by participating in industry conferences/seminars.
  • Must be available and willing to work flexible schedules, as needed.
  • Must be able to travel, up to 30%.
  • Prior experience with GCP and internal audits.
  • Strong working knowledge of problem solving and statistical methods, as applied to clinical studies.
  • Good understanding of medical treatment aspects related to IVDs for allergies and auto-immune diseases.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or regulations.

 

Email your resume directly to Lizelle Cristobal at This email address is being protected from spambots. You need JavaScript enabled to view it.