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About HCLTech
HCLTech is a global technology company, spread across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. We re powered by our people a global, diverse, multi-generational talent - representing 161 nationalities whose unique spark, perspective and boundless passion drive our culture of proactive value creation and problem-solving.
Our purpose is to bring together the best of technology and our people to supercharge progress for everyone, everywhere our clients, partners, their stakeholders, communities, and the planet. As a company, we are deeply focused on accelerating our ESG agenda. We are also creating technology-enabled sustainable solutions with and for our clients and partners. We embed ESG imperatives into every aspect of our business and ensure that the progress we supercharge is responsible, inclusive and beneficial to all our stakeholders in the long term. We have committed to achieving net zero by 2040.

To learn more about how we can supercharge progress for you, visit www.hcltech.com

Senior Technical Specialist with mdr,ISO 13485,mdd

Job Summary
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.

• 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.