Person Responsible for Regulatory compliance

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

Person Responsible for Regulatory compliance

Diagnogen Limited is seeking a Hong Kong-based Regulatory Affairs Manager & Person Responsible for Regulatory Compliance (PRRC) to lead regulatory activities for our IVD products.

Key Responsibilities

Lead EU IVDR compliance, CE marking activities, and regulatory submissions.

Act as the main contact for Notified Bodies, our European Authorised Representative, Obelis, and regulatory authorities.

Oversee technical documentation, performance evaluation, risk management, labelling, and applicable registration requirements.

Work with Production and QA/QC to ensure manufacturing processes, validation records, and product release procedures meet applicable regulatory and ISO 13485 requirements.

Ensure fulfilment of PRRC responsibilities, including conformity checks before release, current technical documentation and Declarations of Conformity, post-market surveillance, and vigilance reporting.

Monitor regulatory developments and coordinate implementation with Production, QA/QC, R&D, After-Sales, Sales, and senior management.

Coordinate audits, corrective actions, and timely resolution of compliance gaps.

Requirements

Meet the PRRC qualification and experience requirements under Article 15 of EU IVDR.

Demonstrated experience in IVD regulatory affairs, ISO 13485, and CE marking.

Practical experience working with Notified Bodies and reviewing technical and manufacturing documentation.

Strong English communication, technical writing, and cross-functional project management skills.

Experience with CLIA/ELISA products and Mandarin proficiency would be advantages.