FUTURE HEALTH WORKS Salary
UNIT 2, SPECTRUM HOUSE 32-34 GORDON HOUSE ROAD LONDON NW5 1LP ENGLAND
TIN: 09336986
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Earnings on positions in FUTURE HEALTH WORKS
FUTURE HEALTH WORKS is looking for employees for positions:
compliance manager
Working hours
- part-time | Permanent
Responsibility
- maintain a robust Quality Management System that meets ISO13485, FDA QSR, EU MDR, and other relevant standards
- drive the maintenance and continuous improvement of the QMS, ensuring compliance and performance
- manage internal and external audits, and ensure timely completion of any necessary corrective and preventive actions
- interface with regulatory agencies during inspections and support regulatory submissions
- participate in product risk management activities in line with ISO 14971
- provide regulatory guidance to cross-functional teams during the product development cycle
- assist in the development and review of technical files and design dossiers
- implement and oversee compliance training for all relevant employees
Requirements
- bachelor's degree in a related field . Advanced degree or relevant certification will be a plus
- minimum of 5 years' experience in quality assurance and regulatory affairs in the digital health/medical device industry or similar
- familiarity with ISO27001, ISO 13485, HITRUST, HIPAA, GDPR, DCB 0129, and other applicable regulations
- experience in conducting and managing internal and external audits
- strong problem-solving skills and attention to detail
- excellent written and verbal communication skills