Senior Technical Lead - MDR, ISO 13485, MDD
United States
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Job Description
Senior Technical Lead - MDR, ISO 13485, MDD
Hamilton,Ohio

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.
Maximum Salary (US):  134000
Minimum Salary (US):  88000
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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 226,300 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 2025 totaled $14.5 billion.

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.