Technical Architect - MDR, 510(k), DHF Remediation
United States
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Job Description
Technical Architect - MDR, 510(k), DHF Remediation
Philadelphia, Pennsylvania

Job Summary

The Technical Architect for Medical Device Regulation (MDR) plays a crucial role in conceptualizing and delivering high-quality solutions that comply with regulatory standards in the healthcare industry. This role requires a strategic mindset to lead the design and implementation of robust architectures, ensuring that product and sustenance delivery aligns with defined scopes and quality benchmarks. The Technical Architect will foster team development and knowledge advancement, making significant contributions to the organization's objectives in delivering compliant and effective medical solutions.

Key Responsibilities

1. Architect And Design Comprehensive Solutions For Product And Sustenance Delivery In Compliance With Mdr Standards, Facilitating Effective Collaboration With The Development Team To Ensure High-Quality Outcomes.
2. Train And Mentor Team Members On Best Practices Related To Mdr Compliance And Architecture, Ensuring The Availability Of Skilled Resources And Mitigating Delivery Risks Through Effective Knowledge Transfer.
3. Lead Initiatives To Stay Abreast Of Emerging Technologies And Regulatory Changes, Incorporating Innovative Solutions Into The Architecture To Meet Evolving Quality Standards And Client Requirements.
4. Gather And Analyze Specifications From Client Organizations To Deliver Tailored Solutions, Leveraging Deep Understanding Of Mdr, Iso 13485, And Clinical Evaluation Processes To Ensure Regulatory Compliance.

Skill Requirements

1. Expert Proficiency In Medical Device Regulation (Mdr) With A Solid Understanding Of Relevant Standards Such As Iso 13485 And Ivdr
2. Extensive Knowledge Of Product Architecture And Design Principles In Regulated Environments
3. Strong Understanding Of Risk Management And Quality Assurance Processes In The Medical Device Lifecycle
4. Excellent Communication And Leadership Skills To Facilitate Team Collaboration And Client Engagements

Other Requirements

1. Optional But Valuable Certifications: Certified In Quality Management Systems (Iso 13485), Certified Quality Auditor (Cqa), Or Similar Relevant Certifications.
Maximum Salary (US):  130000
Minimum Salary (US):  85000
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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.