IVD Regulatory Lead & PRRC (EU IVDR)

Diagnogen Limited; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Diagnogen Limited, based in Hong Kong, seeks a Hong Kong–based Regulatory Affairs Manager & PRRC to lead regulatory activities for our IVD products. The role focuses on EU IVDR compliance, CE marking, and regulatory submissions, serving as the main contact for Notified Bodies, our European Authorised Representative, and regulatory authorities.

Responsibilities include managing technical documentation, risk management, labeling, and registration requirements, and ensuring manufacturing processes

Qualifications

• Demonstrated PRRC qualification under Article 15 of EU IVDR.
• Experience in IVD regulatory affairs, ISO 13485, CE marking.
• Experience with Notified Bodies and regulatory documentation review.
• Strong English technical writing and cross-functional project management.

Responsibilities

• Lead EU IVDR compliance, CE marking activities, and regulatory submissions.
• Serve as main contact for Notified Bodies, European Authorised Representative, and regulatory authorities.
• Oversee technical documentation, risk management, labeling, and registration requirements.
• Coordinate with Production and QA/QC to ensure compliant manufacturing processes and validation records.
• Ensure PRRC duties, including conformity checks, post-market surveillance, and vigilance reporting.

Skills

Regulatory affairs

PRRC qualification

ISO 13485

CE marking

Regulatory submissions

Cross-functional PM

English writing

Mandarin advantageous

Job description

Diagnogen Limited, based in Hong Kong, seeks a Hong Kong–based Regulatory Affairs Manager & PRRC to lead regulatory activities for our IVD products. The role focuses on EU IVDR compliance, CE marking, and regulatory submissions, serving as the main contact for Notified Bodies, our European Authorised Representative, and regulatory authorities.

Responsibilities include managing technical documentation, risk management, labeling, and registration requirements, and ensuring manufacturing processes