Global Regulatory Affairs Analyst – Medical Devices

Varex Imaging Corporation; Laguna; On-site; PHP 420,000 - 660,000; Full time

Job summary

Varex Imaging Corporation seeks a Regulatory Affairs Analyst to support global compliance and product registrations for medical imaging products. You will work with engineering, quality, manufacturing, and commercial teams to bring innovative X-ray devices to market.

The role requires a life sciences or related degree and 2+ years in medical device regulatory affairs, with experience in FDA, EU MDR, ISO 13485, Health Canada, and NMPA. Proficiency in MS Office and QMS/ERP systems is essential.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field.
• 2+ years of experience in medical device regulatory affairs or compliance.
• Experience with FDA, EU MDR, ISO 13485, Health Canada, NMPA, and other global regulations.
• Experience preparing regulatory submissions and technical documentation.
• Knowledge of Class I, II, and/or III medical devices.
• Proficiency in Microsoft Office and QMS/ERP systems.

Responsibilities

• Support global regulatory submissions, renewals, and product registrations
• Maintain technical files, regulatory dossiers, and compliance documentation
• Monitor global regulations and medical device standards
• Partner with cross-functional teams to ensure compliance throughout the product lifecycle
• Support audits, inspections, post-market surveillance, and regulatory strategy

Skills

Regulatory knowledge

Attention to detail

Communication skills

Education

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field

Tools

Microsoft Office

QMS/ERP systems

Job description

Varex Imaging Corporation seeks a Regulatory Affairs Analyst to support global compliance and product registrations for medical imaging products. You will work with engineering, quality, manufacturing, and commercial teams to bring innovative X-ray devices to market.

The role requires a life sciences or related degree and 2+ years in medical device regulatory affairs, with experience in FDA, EU MDR, ISO 13485, Health Canada, and NMPA. Proficiency in MS Office and QMS/ERP systems is essential.