Bangalore, Karnataka

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

2.



Solid 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

Represent the design team and design control process from requirements development and design planning to design transfer& experience with product lifecycle

Lead development of requirements flow down, Architecture/System design and analysis, risk analysis, Cybersecurity analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.

Collaborate closely with cross-functional teams to ensure that regulatory/country specific requirements and outputs are defined.

Work closely with cros

📌 Senior Technical Lead (Bengaluru)
🏢 HCLTech
📍 Bengaluru