QA/RA Specialist

Regulatory Affairs:

• Lead and coordinate regulatory aspects of projects, streamlining communication.
• Handle medical device submissions to regulatory authorities.
• Serve as the point of contact for regulatory project teams and support services on regulatory matters with customers and contractors.
• Maintain the company's product technical file.
• Maintain regulatory databases such as GUDID and EUDAMED.
• Responsible for labeling verification and review to ensure regulatory compliance.
• Manage post-approval changes of labeling, renewals, annual reports, site registration, artwork, etc., and conduct final inspections for labeling manufacturing before release to market.
• Conduct regulatory assessments of changes and their impact.
• Ensure regulatory compliance with products and country requirements.
• Implement all activities in a timely manner, aligning with regional/country strategies and plans.

Quality Assurance:

• Manage quality-related investigations, including complaints, CAPAs, and NCs.
• Conduct QMS maintenance activities related to complaints, CAPAs, NCs, document control, etc.

Competency Requirements:

• 2-3 years of experience working in medical device environments.
• Familiarity with the following standards: EN ISO 20417, EN ISO 15223-1, ISO 13485.
• Strong written and verbal communication skills in English and Hebrew.
• Attention to detail.
• Ability to work effectively in cross-functional teams and independently: organize, plan, and adjust work assignments while meeting deadlines.
• High level of responsibility.
• Excellent communication skills.
• Experience with audits of regulatory bodies and with the CE marking process, including the preparation of technical files.

Qualifications:

• Education: B.A. or B.Sc. from a recognized institute (preferred fields: scientific, biology, QA-related).
• A diploma, certificate, or other evidence of formal qualification in law, medicine, pharmacy, engineering, or another relevant scientific discipline, with at least one year of professional experience in regulatory affairs or quality management systems related to medical devices.
• Alternatively, four years of professional experience in regulatory affairs or quality management systems related to medical devices.