Regulatory and Quality Assurance Specialist II (Remote)

Jackson, MO - USA

Monthly Salary: Not Disclosed

Posted on: 1 hour ago

Vacancies: 1 Vacancy

Job Summary

The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA State Local and AABB).

We have an immediate opening for a Regulatory and Quality Assurance Special II to join our team.

How Youll Contribute

Implement monitor maintain and improve the companys Quality System
Implement monitor and maintain a document control system
Interpret and assure conformance to federal and state regulations that are applicable to the products produced/processed
Assure appropriate licensure is held and maintained by the company
Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
Ensure medical directors complete all signoffs as required
Assure compliance to international regulatory agencies
Tracking and trending of laboratory cryogenic andrology and deviation systems
Maintain and improve deviation/non-conformance system
Report events to regulatory bodies as applicable
Assure training and competency of all staff
Assist in preparation of regulatory strategies for changes to existing systems
Participate in Continuing Education programs in related field
Participate in planning and implementation of regulatory systems document/change control and validation activities
Establish and maintain good working relationships with department heads regulatory authorities and government agencies
Implement and oversee audits for departments and systems to assure compliance to regulations and standards
Track and ensure any identified deficiencies are rectified post an inspection/audit event
Monthly and quarterly in person audits of quality and regulatory manuals and records
Monthly and quarterly reports to leadership on Quality and Regulatory activities

Perform other related duties as assigned by management

The Regulatory and Quality Assurance Special II is responsible for reviewing and implementing the applicable regulatory aspects and quality systems of the company while maintaining compliance with all regulatory agencies (FDA State Local and AABB).We have an immediate opening for a Regulatory and Qu...