SENIOR TECHNICAL SPECIALIST

The Senior Technical Specialist is responsible for leading technical activities related to mdr, ISO 13485, and MDD compliance. This role involves ensuring adherence to regulatory standards and implementing quality management systems within the organization. (1.) Key Responsibilities
1. Develop and implement strategies to ensure compliance with mdr, iso 13485, and mdd regulations. 2. Lead the planning and execution of internal audits to assess compliance levels. 3. Collaborate with cross functional teams to address and resolve compliance issues. 4. Stay updated on changes in regulatory requirements and communicate necessary adjustments to stakeholders. 5. Provide guidance and training to team members on mdr, iso 13485, and mdd standards and practices. Skill Requirements
1. Proficiency in medical device regulation (mdr), iso 13485, and medical device directive (mdd). 2. Strong analytical and problem-solving skills related to compliance and quality management. 3. Excellent communication and interpersonal abilities to work effectively with internal teams and external stakeholders. 4. Attention to detail and a high level of accuracy in regulatory documentation. 5. Project management skills to lead compliance initiatives and audits effectively. Certifications: Relevant certifications in MDR, ISO 13485, or MDD are a plus.

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Tools and Standards (ERS)-Standards - Medical-MDR

1630469BR

Tools and Standards (ERS)-Standards - Medical-ISO 13485

Domain Competencies (ERS)-Medical Devices-Regulatory-MDD