Manager of Quality and Regulatory Affairs
JOB DESCRIPTION:
Overall control, implementation, and maintenance of the Medical Device quality system and quality procedures in accordance with ISO 13485 and FDA GMP including:
- Quality Assurance and Quality Engineering
- Communication to management on the state of the quality system.
- Direct activities of and evaluating performance of quality associates.
- Administration of document system.
- Monitor and facilitate design control program, including design specifications, verification, validation and coordination of design history file.
- Oversee implementation of clinical studies as required for submission to regulatory authorities and notified body.
- Generate, coordinate, and monitor required regulatory submissions.
- Perform surveillance and medical device reporting in compliance with FDA regulations.
- Internal and external audit scheduling and reporting.
- Administration of CAPA system.
- Monitor sterilization validation and dose audit processing.
- Monitor storage and distribution of components and finished goods. Maintain history records.
- Authorize release of product to distribution after final review of records.
- Respond to customer quality inquiries.
- Review and approve of maintenance and calibration of equipment.
- Monitor the preventative maintenance program for manufacturing equipment and facilities.
- Monitor operating procedures and coordinate training of all personnel.
- Strong communication skills, both written and verbal
- Quality Engineering with analysis tools
- Computer literate
- Organized file management
- Management and/or interaction with multilevel staff
EXPERIENCE LEVEL
5-10 years in a pharmaceutical/medical device quality management/regulatory affairs position. Minimum BS Science or Management or equivalent experience in quality assurance positions.