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2 dni temu
The MDR, ISO 13485 Specialist plays a pivotal role in ensuring the company's software complies with Medical Device Regulation (MDR) and relevant standards. This position involves leading the preparation and submission of regulatory documentation, maintaining the quality management system, and ensuring ongoing compliance.
Key Responsibilities:
- Lead the preparation and submission of regulatory documentation for new and existing medical devices in compliance with MDR and ISO 13485 standards.
- Maintain and update the quality management system to ensure ongoing compliance with MDR, ISO 13485, and ISO 14971 standards.
- Conduct gap analyses and implement necessary changes to meet regulatory requirements.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
- Monitor and track regulatory changes and provide guidance on their impact.
- Support the preparation of post-market surveillance reports, adverse event reports, and other regulatory submissions as required.
- Support internal and external audits by clients and regulatory bodies.
- Provide training and support to staff on regulatory requirements and quality management systems.
Qualifications:
- Bachelor's degree in a scientific, engineering, or related discipline.
- Experience in regulatory affairs and quality management systems in the medical device industry preferred.
- Strong knowledge of MDR and ISO 13485 standards and requirements.
- Experience with regulatory submissions to global regulatory bodies preferred.
- Excellent project management, analytical, and organizational skills.
- Strong communication and interpersonal skills.
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