Job Opportunities

We are a rapidly growing medical device company, developing an innovative line of therapeutic products which provide effective, easy-to-use and affordable treatment to some wide spread diseases and medical conditions. Our first product, the Nerivio Migra, an electronic patch for acute treatment of migraine, has successfully completed a clinical study with 86 patients in one of the largest hospitals in Israel.

Headquartered in Netanya, Israel, we offer a challenging work environment with global reach, while maintaining a small company, employee-focused atmosphere.

We’d love to see you as part of the Theranica family!
Check out the positions below, and feel free to send us your resume to info@theranica.com

CRA – Clinical Research Associate

 

Responsibilities

  • Ensure clinical studies are conducted in compliance with the respective investigational plan, procedures and all applicable regulations (ICH-GCP regulations, 21 CFR).
  • Support clinical sites with preparation and submission of required documentation to Institutional Review Boards. Ensure maintenance of IRB approval throughout the duration of the study, and ensures compliance with national and international regulations.
  • Provide training to clinical sites regarding protocol requirements, data collection, operation of study devices etc.
  • Maintain daily follow-up of study progress and conduct periodic site monitoring visits. Verify data accuracy and as part of data management performs data entry/verification.
  • Provide clinical status reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators and senior management.
  • Support in scientific and marketing publications
  • Develop collaborative relationships and networking with PI’s, SSC and related subcontractors participate in the study (statistician, EDC developers)

Required Skills

  • 5-10 years of experience in clinical trials in the medical device industry
  • Strong knowledge of GCP and other regulatory requirements
  • Excellent oral and written English language skills
  • Overseas travel of up to 30%-40%
  • Good analytical skills


Required Education:

  • Sc. in life science or higher/medical science

Quality Manager

The Quality Manager is responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS).

 

Responsibilities

  • Ensure that the organization’s Quality Management System conforms to customer, internal, select ISO standards (as per management definitions) and regulatory/legal requirements
  • Ensure evaluation of, and reporting on, vendor quality systems
  • Oversee inspection (examination) of incoming materials, ensuring that they meet requirements
  • Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products
  • Assimilate, validate and verify a QMS system
  • Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement
  • Conduct periodic management review meetings
  • Oversee product recalls and investigate customer complaints
  • Prepare the company for, and oversee internal and external audits of Notified Bodies and FDA
  • Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices
  • Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality

 

Skills and Education

A bachelor’s degree in engineering or quality is required, as is 3-5 years of experience in Quality Assurance/Quality Control in medical devices, preferably as a Quality Manager. Current CQA or similar certification is required.

Proven experience with submitting (and passing) medical products to CE and/or FDA.

Excellent communication skills and the ability to work well with people at all levels are essential. Must have strong organizational, analytical, problem solving, and management skills. Experience with MS-Office (especially Excel, Word) is needed. Project management experience is a plus.


Reporting

Reports directly to the Director of Quality or a designated management member. Works in conjunction with Procurement, Production, and any other department that has an effect on the quality of the organization’s products.