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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 Lead with mdr,ISO 13485,mdd

Job Summary
As a Senior Technical Lead specializing in mdr,ISO 13485, and mdd, the primary responsibilities include overseeing the technical aspects of projects related to medical device regulations and standards compliance. The role involves ensuring adherence to ISO 13485 quality management systems and the Medical Device Directive (MDD).

• Key Responsibilities
  1. Lead technical teams in the implementation and maintenance of systems compliant with iso 13485 and mdd requirements.
  2. Provide expertise on mdr regulations and guidelines to ensure product development and validation processes meet the necessary standards.
  3. Collaborate with cross functional teams to align technical strategies with regulatory requirements.
  4. Conduct audits and assessments to verify compliance with mdr, iso 13485, and mdd requirements.
  5. Develop and implement strategies to address technical challenges and optimize processes in compliance with medical device regulations.
  
  Skill Requirements
  1. Proficiency in interpreting and applying mdr regulations, iso 13485 standards, and the medical device directive (mdd).
  2. Strong technical leadership skills to guide teams in achieving compliance goals effectively.
  3. Excellent communication skills to interact with stakeholders and convey technical requirements clearly.
  4. Analytical thinking to assess complex technical issues and develop appropriate solutions.
  5. Detail oriented approach to ensure accuracy and precision in compliance related tasks.
  
  Certification in Medical Device Regulations (MDR) or ISO 13485 is a plus.