Senior Technical Lead - MDR, ISO 13485, MDD

Experience: 5 to 10 years

Location: Bangalore, India

Skills: MDR regulations, ISO 13485 standards, Medical Device Directive (MDD), technical leadership, analytical thinking, detail oriented, Certification in Medical Device Regulations (MDR), Certification in ISO 13485

Job Summary
sub-system, system, board level testing. Need to have product level understanding, troubleshoot field issues. knowledge on IEC60601-1 standard Verification test case authoring and execution

Job Purpose:
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.



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:
1. Certification in Medical Device Regulations (MDR) or ISO 13485 is a plus.
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.

📌 Senior Technical Lead MDR, ISO 13485, MDD (Bengaluru)
🏢 HCL Technologies
📍 Bengaluru