Project Manager – IVD

Department: Product Development

Reports To: Senior Manager

Duties and responsibilities may be added, deleted, or changed at any time at the discretion of management, formally or informally, in either verbal or written form.

Simplifying diagnostics. Improving global health. Located in San Diego, CTK Biotech develops and manufactures innovative immunodiagnostic tools and point of care diagnostic test kits for the IVD community worldwide.

Work Environment

Equal Opportunity Employer

Essential Duties and Responsibilities

Manage product life cycle from its initiation, development, and postmarketing support based on relevant standards and regulations. Duties include the following.

  • Analyze product demand, competition and postmarket feedback.
  • Assist in management of the entire product development and improvement process through close communication with R&D team, QA/RA team, marketing team, purchasing team.
  • Assist in documentation of design history files, technical files, and regulatory submissions.
  • Acquire specimens and reference tests, coordinate product evaluation studies.
  • Provide technical support to sales staff and global customers. Help in handling product complaints.
  • Support development of product marketing material.

Other duties may be assigned.

Education and/or Experience

BSc or MS in Biomedical Science. Marketing experience a plus. Experience in IVD, infectious disease, biomarker, microbiology or immunoassays is preferred.

Preferred Knowledge, Skill and Experience                       

Computer Skills:

  • To perform this job successfully, an individual should be proficient in Microsoft Office including Excel Spreadsheets, Power Point, and Word. Adobe Photoshop and Illustrator is a plus.

Other Skills and Abilities:                                                  

  • Strong literature search and analytic skills are essential.
  • Excellent project management skills.
  • Superior English speaking and writing.
  • Excellent technical writing skill.
  • Ability to multi-task.
  • Strong attention to detail.

  • Accepted file types: pdf, doc, docx.
  • This position will be located at our new extended facility in Poway (near Costco), California.

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