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RA/QA Director

  • Location

    Other Locations

  • Salary


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    Alex Williams

  • Published

    19 days ago


We are seeking an experienced Regulatory and Quality Assurance leader to direct and coordinate the
organizations activities in support of the quality system and both domestic and international regulatory

Essential Functions:
* Responsible for developing worldwide clinical and regulatory strategies to support marketing
applications and corporate requirements
* Supports medical device clinical trials to support regulatory submissions, data integrity, and
promotional claims
* Manages the preparation of regulatory submissions, including IDE's, 510(k)'s, Technical Files,
Design Dossiers, and other international submissions
* Maintains the registration, listing, licenses, and certificates from federal, state, and international
regulatory agencies
* Represents the company as Management Representative and primary interface with FDA, State
of California, Notified Body, and other medical device regulatory agency inspectors
* Oversees transition from MDD to EU-MDR in an effective and timely manner
* Develop strong relationships with key opinion leaders and key regulatory agency personnel
* Reviews and approves new and modified product labeling and promotional materials for
compliance with product specifications and domestic and international labeling and promotional
* Ensures the establishment, implementation, and maintenance of the quality system in
compliance with FDA, ISO, and other regulations, standards, and internal procedures
* Reports on compliance and effectiveness of the quality system to USGI Management at regular
* Manages the Quality Department including Quality Control and Document Control

Supervisory Responsibilities:
* Supervision of Quality Engineer and QC inspectors

Qualifications & Skills:
* Global Quality and Regulatory Affairs background with extensive knowledge of FDA, ISO, and EU
* In-depth knowledge and experience with quality system and regulatory processes including
regulatory submissions, risk management, complaint handling, CAPA, NCR management, design
control, manufacturing quality support, quality metrics, and global registrations
* Extensive expertise with external regulatory agencies during audits and inspections
* Understanding of EU-MDR requirements and experience with EU-MDR transition
* Ability to act as a strategic partner with Upper Management and interface with internal and
external customers
* Strong leadership and managerial skills
Education & Experience:
* Bachelor's Degree in Engineering or Life Sciences
* Minimum 6 or more years' related experience in the medical device industry