Spec RA GSO (Medical Devices)

Location: Wuhan, China

Company

hirify.global develops and supplies healthcare products, including medical devices and related regulated products.

What you will do

• Review hirify.global-branded labeling for commodity, medical device, drug, and cosmetics products against internal procedures and applicable federal laws and regulations.
• Compare designed labeling with product manager requests and mock-ups, and coordinate issue resolution with product managers, quality assurance, designers, and regulatory affairs colleagues.
• Archive approved labels according to internal procedures and instructions.
• Communicate with suppliers to support effective labeling implementation and lead labeling-related problem solving and improvement.
• Investigate labeling problems, conduct corrective actions, and participate in labeling project planning and implementation.
• Provide regulatory and risk-assessment advice and train new hires on labeling review processes.

Requirements

• Experience or knowledge in regulatory affairs, product labeling, and applicable medical device or other regulated-product requirements.
• Ability to coordinate with product management, quality assurance, design, regulatory affairs, suppliers, and project leaders.
• Ability to investigate labeling issues and support CAPA and SCAR activities.
• Ability to review regulatory information and provide input during risk assessment and problem solving.

Nice to have

• Experience collecting and maintaining UDI and FDA product registration data in hirify.global and GUDID systems.
• Experience with adverse-event searching and analysis for CE-marked devices.
• Experience preparing certificates of conformity and Declarations of Conformity.

Culture & Benefits

• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working an average of 30 or more hours per week.
• Employees working fewer than 30 hours per week receive 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
• Inclusive workplace focused on belonging, diversity, career growth, and providing employees with tools and resources to perform effectively.