Technical Architect - MDR, 510(k), DHF Remediation
Netherlands
Apply now
Job Description
Technical Architect - MDR, 510(k), DHF Remediation
Utrecht, Utrecht

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.
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 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.
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.