Position Overview: The Medical Device Product Reviewer will be responsible for conducting thorough reviews of medical device documentation to ensure compliance with relevant regulations and standards. The role involves detailed technical assessments, risk evaluations, and collaboration with clients to facilitate the certification process.
Key Responsibilities:
- Review and evaluate technical documentation for medical devices, including design dossiers, technical files, and clinical evaluation reports.
- Assess conformity of medical devices with applicable regulations, including EU MDR (Medical Device Regulation) and other relevant international standards.
- Conduct risk assessments and evaluate clinical evidence provided by manufacturers.
- Communicate 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 to verify compliance with quality management systems.
- Stay updated with current and emerging regulations, standards, and industry practices related to medical devices.
- Provide support and expertise to internal teams and stakeholders on medical device-related matters.
- Contribute to continuous improvement initiatives within the organization.
Qualifications:
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 2 years of active experience in the medical device industry, with hands-on experience in product development, quality assurance, or regulatory affairs.
- In-depth knowledge of EU MDR and other relevant regulatory requirements for medical 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 medical device 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 medical technologies and products.
