Regulatory Affairs Senior Specialist/Manager/Director

Department: Regulatory Affairs

Reports To: Director, QA & RA

CTK Biotech develops, manufactures and markets diagnostic kits worldwide. Its focus is on infectious diseases and biomarkers. It intends to recruit highly motivated scientists for its product development team to manage its growing product lines.

Position Summary

CTK is looking for an experienced regulatory professional to join our team as we expand our already large product portfolio into new technologies and markets.  CTK is a fast-paced IVD manufacturer, delivering and improving diagnostics across the world. Our employees get the experience of working with our international facilities and directly communicating with our customers found in over 120 countries! As you bring your experience and talent to the global market, you will make a positive impact to global healthcare by promoting an array of products, from simple test kits to digital diagnostic instrumentation solutions.

Work Environment

Equal Opportunity Employer. Reasonable accommodations are available for qualified individuals with disabilities, upon request.

Essential Duties and Responsibilities

  • Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements.
  • This position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
  • Identifies and drafts domestic and international strategies and registration plans and options to obtain product approvals and support product changes.
  • Prepares or oversees the preparation of regulatory submission plans for both domestic and international submissions.
  • Evaluates change control activities to assess regulatory impact on submissions and filing requirements. Provides regulatory affairs assessment for change control documents to ensure compliance to regulations and notification of significant changes to the respective regulatory authority body. Provides regulatory opinion for complex or unique issues and challenges regarding registration and compliance activities.
  • Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
  • Perform regulatory assessment of new and changed products.
  • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
  • Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
  • Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
  • Participate in business meetings with potential new external partners
  • Interacts with regulatory agencies with facilities inspections, licensures and permits.
  • Supports regulatory compliance to QSR, ISO, CMDR, IVDD/IVDR, USDA and other worldwide regulatory requirements as appropriate through customer complaints, internal audits and training systems.
  • Reviews, interprets, and communicates FDA/international regulations and guidance documents to ensure complete and scientifically sound product submissions. Research regulations and competitor products and create summaries for departmental use.

Education and/or Experience

  • 5 years minimum Regulatory Experience in IVD
  • BS in life science minimum
  • Strong understanding of various diagnostic techniques including molecular and related instrumentation
  • Exceptional public speaking skills needed to represent corporation at external meetings, conferences and organizations.
  • Executes sound judgment, analyzes issues, thinks strategically, creatively, and uses innovative ideas.
  • Able to present high level information for multiple audiences.
  • Experience organizing and communicating technical information
  • Demonstrates exceptional problem solving, decision-making, conflict management, change management and negotiating skills.
  • Excellent written and verbal communication skills.

Preferred Knowledge, Skill and Experience                     

  • cGMP for Medical Devices
  • ISO 13485
  • FDA and (New) EU Medical Device or IVD regulation
  • Excellent verbal and writing communication skills
  • Excellent skills in writing reports and procedures
  • Analytic and detail oriented
  • Punctual and reliable

  • 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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