QA/RA Director

Responsibilities:

Define, implement and maintain the effectiveness of the quality management system in the company in compliance with the requirements of ISO 13485 and 21 CFR Part 820.

Act as management representative responsible for quality management system requirements and applicable regulatory requirements throughout the organization.

Responsible for managing and coordinating of all regulatory submissions and registries to FDA (PMA class III device), EU and other regulatory bodies world-wide per company regulatory strategy.

Responsible for company’s regulatory requirements compliance (for all teams’ activity, including R&D and Marketing) and for the company’s regulatory records.

Responsible for quality system training.

Monitor QA aspects of subcontractors’ activity.

Manage and control the processes of nonconforming products/material (including the material review board (MRB)), corrective and preventive actions and customer complaints handling.

Report to the top management on the performance of the quality system, including needs for improvement.

Prepare and implement the internal audit plan, initiate and document corrective actions.

Evaluate suppliers, subcontractors, external services, etc. on quality issues.

Coordinate testing by external laboratories.

Lead and support Quality Control activities, including receiving inspection and final batch and product release to stock.

Manages the review and approval process of all products advertising and labeling to determine compliance with global labeling requirements.

Experience:

Bachelor’s degree required (preferably in an engineering or chemistry or biotechnology fields) or equivalent in work experience.

5+ years of experience in QA/RA positions.

Deep experience in submissions and communication with FDA (510k or PMA) and notified bodies (class II medical devices or higher).

Solid understanding and proven of ISO 13485, 21 CFR 820 QSR, ISO 14971.

Solid understanding and experience in analytical methos, chemical analysis, and analysis of polymeric and degradable materials

Excellent English and effective verbal communication and writing skills including with American/European advisors.

Advantageous:

Familiarity with medical synthetic polymers or polymer chemistry or electrospinning techniques

Familiar with MDR requirements.

Qualification and experience as an internal auditor