
Medical Devices Technical Lead
6 hours ago
A seasoned Medical Devices Technical Lead is required to drive technical excellence and ensure compliance with regulatory standards. This role involves assessing and auditing medical devices, leveraging expertise in quality management and risk mitigation.
Main Responsibilities:- Lead Audits and Assessments: Conduct thorough audits and assessments of medical devices, ensuring adherence to ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR.
- Risk Management Guidance: Provide expert guidance on risk management practices, utilizing experience with EN ISO 14971.
- Team Collaboration: Collaborate with a team of experts to deliver high-quality services and maintain technical excellence.
- Mastery of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
- Experience in quality management, focusing on non-active devices and sterilization processes.
- 10+ years of professional experience in healthcare products or related activities.
The ideal candidate will have a strong background in medical devices, quality management, and risk assessment. They will be able to drive technical excellence, lead teams, and ensure compliance with regulatory standards.
Key Requirements:- Technical Expertise: Demonstrated expertise in medical devices, quality management, and risk assessment.
- Leadership Skills: Proven ability to lead teams and drive technical excellence.
- Regulatory Knowledge: In-depth understanding of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
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