About The Position
The Director of Quality and Regulatory Affairs will champion, support or lead quality improvement initiatives as well as strategizing, supervising and executing regulatory work for the Company. He or she is responsible for ensuring that all managers, process owners, and supervisors develop and maintain their part of the quality management system.
- The Director of Quality and Regulatory Affairs, along with management and QA team, is responsible for ensuring the quality of products, processes and services for LabStyle in accordance with applicable regulatory requirements.
- Translates regulations, requirements, and guidelines into company policy/procedures and trains personnel accordingly.
- Develop and monitor appropriate quality metrics for review by management including inputs into the management review process. Participates and contributes to management review.
- Evaluates sources of processes to determine root causes and to implement appropriate corrective and preventive actions. Ensures effectiveness of corrective and preventive actions implemented.
- Develop and monitor an Effective Complaint Management System
- Work to manage and facilitate local quality system assessments including, but not limited to internal and third party inspections.
- Manages with QA team corrective and preventive action (CAPA) and change order (CO) processes.
- Coordinates ongoing enhancement and harmonization of quality systems.
- Develops employees and evaluates work performance in order to maximize employee's potential and impact on the organization.
- Provides environment for professional development of personnel though regular evaluations, counselling and oversight.
- Internal and external audits including supplier approval and evaluation.
- Supervises, guides and executes RA activities of the Company
- Prepares, submits and communicates submissions to regulatory agencies/authorities worldwide.
- Prepares regulatory strategies/plans and worldwide compliance requirements. Provides on-going support to project teams for regulatory issues and questions.
- Reviews sales and marketing materials for regulatory compliance
- Maintains Regulatory Affairs product files to support compliance with regulatory requirements.
- 5 or more years of work experience including 3 or more years of relevant quality system experience in a medical device, pharmaceutical, aerospace, automotive or other highly regulated environment.
- 3 or more years of experience providing work direction and leadership to people and teams preferred.
- Previous experience with ISO/CE certification process required
- Previous experience with US and international medical device regulations required
- In-depth knowledge of the following preferred: ISO 13485, ISO 14971, EU Directives and CFR 21 Part 820.
- Excellent Communications Skills both written and verbal.
- Bachelor's Degree required
- Master's Degree preferred