Regulatory Affair Specialist

Qualification:

Job Summary:

• We are seeking a highly skilled

  Regulatory Affairs Specialist

  with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR.
• The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products.
• In addition to EU IVDR compliance, the candidate will support

  global product registration efforts

  , including preparation of regulatory documentation for submission in multiple markets. The role requires collaboration with cross-functional teams to ensure

  timely and accurate preparation of regulatory documents

  , risk files, and performance data packages for international regulatory approvals.
• Familiarity with immunoassays, including ELISA and fluorescence-based methods, particularly for infectious disease diagnostics, is preferred.

Key Responsibilities:

1. Performance Evaluation Documentation:

• Author and maintain IVDR-mandated performance evaluation documents, including:
• Scientific Validity Reports (SVRs)
• Analytical Performance Reports (APRs)
• Clinical Performance Reports (CPRs)
• Performance Evaluation Reports (PERs)
• Ensure alignment with EU IVDR Annex XIII, MDCG guidelines, and ISO standards.
• Compile and interpret data from internal validations, clinical studies, and external literature.
• Coordinate with laboratory/R&D teams to ensure appropriate data generation for APRs and CPRs.

2. Scientific Validity & Literature Review:

• Conduct systematic literature searches using PubMed, Embase, Scopus, and other databases.
• Define and document search strategies, selection criteria, and appraisal methodology.
• Evaluate and synthesize scientific evidence supporting biomarkercondition associations.
• Develop literature matrices, evidence tables, and justification summaries for SVRs.

3. Regulatory Documentation & Global Registration Support:

• Prepare and maintain CE Technical Files/Design Dossiers and ensure alignment with GSPRs.
• Support

  global product registration activities

  by preparing and submitting regulatory documentation as per country-specific requirements.
• Ensure

  timely preparation and submission of documents

  for new market approvals and renewals.
• Assist in regulatory gap assessments and remediation planning for international markets.
• Contribute to Risk Management Files (ISO 14971) and Post-Market Performance Follow-up (PMPF) documentation.

4. Cross-Functional Coordination & Audit Support:

• Collaborate with RA, QA, R&D, PMS, and manufacturing teams for data collection and alignment.
• Participate in internal audits and assist with responses to Notified Body and regulatory authority observations.
• Support vigilance reporting and post-market analysis through literature and performance data review.

Required Skills & Experience:

• 5-7 years of experience in regulatory affairs and clinical/performance documentation for IVDs or medical devices.
• In-depth knowledge of EU IVDR, ISO 13485, ISO 20916, CLSI guidelines, and applicable international regulatory standards.
• Proven experience in preparing performance evaluation documents and conducting systematic literature reviews.
• Strong understanding of immunoassay technologies and infectious disease diagnostics.
• Excellent documentation, data analysis, and regulatory writing skills.