Technical Specialist - MDR, 510(k), DHF Remediation
United States
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Job Description
Technical Specialist - MDR, 510(k), DHF Remediation
Delaware, Indiana

Job Summary

The Technical Specialist in Medical Device Regulations (MDR) plays a pivotal role in conceptualizing, designing, and delivering high-quality product solutions within the established scope and standards. This position is vital for ensuring compliance with regulatory requirements, driving innovation, and enhancing the overall effectiveness of product sustenance delivery through team collaboration. The role emphasizes strategic contributions to projects, mentoring team members, and maintaining cutting-edge knowledge in medical device technologies.

Key Responsibilities

1. Architect, Design, And Develop Comprehensive Solutions by Leveraging Team Expertise in Regulatory Frameworks and Standards, Ensuring Compliance with Iso 13485 And other applicable regulations throughout The Product Lifecycle. 
2. Serve As a Subject Matter Expert (SME) in MDR, Providing Technical Guidance and Insights on Regulatory Requirements to Support Project Objectives and Client Needs. 
3. Ensure Continuous Knowledge Enhancement by Researching and Integrating New Technologies Related to applicable medical device regulations, thus Guaranteeing that Solutions Remain Current, Innovative, And Aligned with Industry Best Practices. 
4. Train And Mentor Team Members on Processes and Standards, fostering a skilled Workforce Capable of Delivering on Project Expectations while mitigating potential Risks. 
5. Gather And Analyze Specifications to Develop Tailored Solutions for Client Organizations, Applying A Deep Understanding of Medical Device Regulations and Technology Applications.
6. Conduct Thorough Reviews of Project Deliverables to Ensure Compliance with Requirements, Quality Standards, And Client Specifications. 
7. Recommend and implement client value creation initiatives based on a robust Understanding of Industry Trends and Best Practices in Regulatory Compliance, Positioning the Organization as a Leader in the Field.

Skill Requirements

1. Expert Knowledge of 21CFR820, Iso 13485, ISO 14971, And Other Related Regulatory Frameworks. 
2. Advanced Proficiency In Project Management And Product Development Processes.
3. Strong Understanding Of Quality Management Systems And Compliance Standards In The Medical Device Industry.
4. Excellent Analytical And Problem-Solving Skills With The Ability To Drive Solutions Effectively.
5. Proven Ability To Mentor And Develop Technical Teams In Specialized Regulatory Practices.

Other Requirements

1. Certification In Regulatory Affairs (Rac) Is Desirable but Not Mandatory.
2. Iso 13485 Lead Auditor Certification Is Optional but Valuable.
3. CQE certification is preferred but not mandatory
Maximum Salary (US):  172000
Minimum Salary (US):  87000
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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 227,000 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 March 2026 totaled $14.7 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.