Regulatory Affairs and Medical Device QA Specialist

We are hiring an RA and QA specialist with some FDA-related experience:

• Class two medical device.
• Surgical robotics system and imaging.
• Full-time or part-time (flexible commuting hours).
• Located in Har Hotzvim, Jerusalem.

The RA and QA specialist will be handling the Regulatory Affairs and Quality Assurance in the organization.

Roles and Responsibilities:

• Prepare QA procedures.
• Prepare post-marketing reports.
• Manage design validation & verification, and design history files.
• Follow regulatory pathways and regulatory plans.
• GAP analysis for new standards/guidance documents.
• Prepare annual management reviews.
• Liaise with regulatory bodies (FDA, NB, etc.)
• Preparation of regulatory files (EU Technical Files, FDA submissions, etc.)
• Ensure documents comply with current regulations and regulatory guidance.
• Familiar with quality management systems including 21 CFR 820, ISO 13485 (2016), MDD & CE marking, and MDSAP.
• Manage the quality-related activities. (ECO, MRB, CAPA, training, and qualifications. Internal and external Audits)
• Provide regulatory strategic direction on projects/products

Skills and Requirements:

• Excellent oral and written communication skills in English.
• Bachelors in sciences (or higher) or engineering.
• At least two years of experience in RA&QA.
• Self-learner and team player.

FULL TIME

PART TIME

Jerusalem

Hi-techQuality Assurance