Project Lead
HCL
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
Technical lead with mdr,ISO 13485,mdd
Job Summary
The Technical Lead for mdr, ISO 13485, and MDD is responsible for leading technical activities related to medical device regulations compliance, including ISO 13485 and Medical Device Directive (MDD) requirements. The role involves overseeing the development and maintenance of processes and systems to ensure adherence to regulatory standards in the healthcare industry. (1.) Key Responsibilities
1. Lead technical initiatives to achieve compliance with medical device regulations, specifically iso 13485 and mdd.
2. Develop and implement strategies to ensure that products meet the necessary quality and safety standards.
3. Collaborate with cross functional teams to integrate compliance requirements into product development processes.
4. Conduct audits and assessments to identify gaps in compliance and implement corrective actions.
5. Stay updated on changes in regulations and standards related to medical devices and ensure timely implementation within the organization.
Skill Requirements
1. In-depth knowledge and experience with medical device regulation (mdr), iso 13485, and medical device directive (mdd).
2. Strong understanding of quality management systems in the context of medical devices.
3. Proficiency in interpreting and applying regulatory requirements to product development processes.
4. Excellent communication skills to effectively engage with internal teams and external stakeholders.
5. Attention to detail and strong analytical skills to assess compliance gaps and propose solutions.
Certifications: Relevant certifications in medical device regulations (e.g., Certified ISO 13485 Lead Auditor) would be advantageous.
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
Technical lead with mdr,ISO 13485,mdd
Job Summary
The Technical Lead for mdr, ISO 13485, and MDD is responsible for leading technical activities related to medical device regulations compliance, including ISO 13485 and Medical Device Directive (MDD) requirements. The role involves overseeing the development and maintenance of processes and systems to ensure adherence to regulatory standards in the healthcare industry. (1.) Key Responsibilities
1. Lead technical initiatives to achieve compliance with medical device regulations, specifically iso 13485 and mdd.
2. Develop and implement strategies to ensure that products meet the necessary quality and safety standards.
3. Collaborate with cross functional teams to integrate compliance requirements into product development processes.
4. Conduct audits and assessments to identify gaps in compliance and implement corrective actions.
5. Stay updated on changes in regulations and standards related to medical devices and ensure timely implementation within the organization.
Skill Requirements
1. In-depth knowledge and experience with medical device regulation (mdr), iso 13485, and medical device directive (mdd).
2. Strong understanding of quality management systems in the context of medical devices.
3. Proficiency in interpreting and applying regulatory requirements to product development processes.
4. Excellent communication skills to effectively engage with internal teams and external stakeholders.
5. Attention to detail and strong analytical skills to assess compliance gaps and propose solutions.
Certifications: Relevant certifications in medical device regulations (e.g., Certified ISO 13485 Lead Auditor) would be advantageous.
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