Senior Technical Lead - MDR, ISO 13485, MDD
India
Apply now
Job Description
Senior Technical Lead - 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.

Other Requirements

1.Certification in Medical Device Regulations (MDR) or ISO 13485 is a plus.
Apply now
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 220,000 people 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. Consolidated revenues as of 12 months ending December 2024 totaled $13.8 billion.
23 Benefits At HCLTech, we believe in empowering our employees with comprehensive benefits that support their professional growth and enhance their well-being. When you sign up for a career with us, you gain access to: https://rmkcdn.successfactors.com/147eb21f/a701dca9-f32d-4fc9-9447-6.svg Industry-benchmarked compensation https://rmkcdn.successfactors.com/147eb21f/b0c54381-ddcc-4a33-9b35-9.svg Best-in-class healthcare benefits https://rmkcdn.successfactors.com/147eb21f/b73027be-7aae-4d36-a090-4.svg Personal time off https://rmkcdn.successfactors.com/147eb21f/d5b4fdfd-2e99-4e26-9878-9.svg Maternity and paternity benefits https://rmkcdn.successfactors.com/147eb21f/3d42b0fc-4652-435a-9ece-c.svg Access to skills / higher education programs/resources https://rmkcdn.successfactors.com/147eb21f/aeddeaf2-9e25-4584-ad11-d.svg Discounts on products and services via Benefit Box https://rmkcdn.successfactors.com/147eb21f/a9609a3b-2700-4b3c-9d90-a.svg Participate in CSR programs and live life with a purpose https://rmkcdn.successfactors.com/147eb21f/c6e33851-710f-4634-bd69-f.svg Opportunities to grow and advance your career Note: The benefits listed above vary depending on the nature of your employment and the country where you work. Some benefits may be available in some countries but not in all.