RA/QA Specialist @ DreaMed Diabetes - February 2020

28 February 2020
Location: Petah Tikva

Job Description:

Position description:

DreaMed is looking for a highly organized and motivated Regulatory Affairs and Quality Assurance
Specialist who will join the team and help maintain the Quality Management System and support
company regulatory activities. The RA/QA Specialist will provide support and guidance for all
company activities including: clinical studies, product design and development and post-market
related activities.

Job Responsibilities:

  • Write and update company quality procedures and ensure their effective implementation
    across the organization
  • Help maintain the quality system including: Document & Record Control, Internal Audits, ECO, Training, CAPA, Supplier Control, Quality Planning, etc.
  • Participate in internal audits and external annual Notified Body audits
  • QA review and approval of documents, records and final product release
  • Communicate with European Authorized Representative and Notified Body
  • Manage company labeling
  • Perform gap analysis of updated relevant standards, guidance documents and regulations and communicate the requirements to relevant company functions
  • Maintain European Technical File

Required Qualifications:

Qualification Requirements:

  • 1-3 years experience working in medical device industry within the quality and regulatory environment including knowledge of ISO 13485:2016, IEC 62304:2006, EN ISO 14971:2016
  • Knowledge and experience in writing and updating company procedures
  • Preference to experience from digital health industries
  • Bachelor’s degree in a related field
  • English- mother tongue
  • Must demonstrate good computer skills and be able to embrace new technologies

Preferred Personal Qualifications:

  • Must be extremely detail-oriented and organized
  • Must be able to collaborate with different teams in the company yet enforce the rules and regulations
  • Excellent communication, presentation and interpersonal skills.
  • Multi-tasker: ability to multi-task and work on several projects simultaneously
Apply to This Job Here: DreaMed Diabetes Website