Position Overview: The IVD Product Reviewer will be responsible for evaluating in vitro diagnostic medical devices to ensure they meet regulatory requirements and standards. This role involves detailed technical assessments, documentation reviews, and collaboration with clients to facilitate the certification process.
Key Responsibilities:
- Conduct comprehensive reviews of technical documentation for IVD products, including design dossiers, technical files, and performance evaluation reports.
- Assess conformity of IVD devices with applicable regulations, including EU IVDR (In Vitro Diagnostic Regulation) and other relevant international standards.
- Perform risk assessments and evaluate clinical evidence provided by manufacturers.
- Liaise with clients to clarify technical and regulatory requirements, providing guidance and feedback to ensure compliance.
- Prepare detailed review reports, summarizing findings and recommendations.
- Participate in audits and inspections as needed to verify compliance with quality management systems.
- Stay updated with current and emerging regulations, standards, and industry practices related to IVD devices.
- Provide support and expertise to internal teams and stakeholders on IVD-related matters.
- Contribute to continuous improvement initiatives within the organization.
Qualifications:
- Bachelor's degree in Biomedical Engineering, Biotechnology, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 3 years of experience in the medical device industry, with specific experience in IVD products.
- In-depth knowledge of EU IVDR and other relevant regulatory requirements for IVD devices.
- Experience with technical documentation review, risk assessment, and clinical evidence evaluation.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a multidisciplinary team.
- Attention to detail and strong organizational skills.
- Certification in regulatory affairs (e.g., RAC) or quality management systems (e.g., ISO 13485) is a plus.
Key Competencies:
- Regulatory Expertise: Thorough understanding of IVD regulations and standards.
- Technical Proficiency: Ability to interpret and assess complex technical documents.
- Communication: Clear and effective communication with clients and internal teams.
- Analytical Thinking: Strong analytical skills for evaluating clinical and technical data.
- Detail-Oriented: High attention to detail in documentation review and reporting.
- Team Collaboration: Ability to work collaboratively within a team environment.
Benefits:
- Competitive salary and performance-based incentives.
- Comprehensive health and wellness benefits.
- Professional development and training opportunities.
- Supportive and collaborative work environment.
- Opportunity to work with cutting-edge IVD technologies and products.
