Senior Technical Specialist MDR, 510(k), DHF Remediation

Job description

The Senior Technical Specialist in Medical Device Regulation (MDR) will play a pivotal role in conceptualizing, designing, and delivering product lifecycle solutions within the organization. This position requires a profound understanding of regulatory frameworks and industry-leading practices, contributing significantly to project advancements and ensuring compliance with stringent standards. The role demands leadership in driving innovation and optimizing processes, ultimately enhancing the quality and success of project outcomes. Key Responsibilities 1. Architect And Design Comprehensive Solutions For Product And Sustenance Delivery In Compliance With Mdr And Iso 13485 Standards, Ensuring Quality And Regulatory Adherence. 2. Serve As A Subject Matter Expert (Sme) In Mdr, Providing Strategic Guidance And Insights To Cross-Functional Teams And Stakeholders Throughout The Project Lifecycle. 3. Conduct Ongoing Research And Implement New Technologies In Mdr To Ensure Solutions Are Contemporary, Effective, And Aligned With Client Requirements And Industry Standards. 4. Develop A Skilled Workforce In The Mdr Domain By Conducting Interviews, Leading Training Sessions, And Providing Mentorship To Build A Capable Team Of Professionals. 5. Gather Detailed Specifications And Deliver Tailored Solutions To Client Organizations, Leveraging Deep Domain Knowledge Of Medical Device Regulations And Technologies. 6. Support Competency Development By Envisioning And Articulating Value Propositions, Including The Creation Of Marketing Collateral, Whitepapers, And Conducting Market Trend Analyses To Drive Business Growth. 7. Recommend Client Value Creation Initiatives By Implementing Industry Best Practices In Mdr, Ensuring The Organization'S Offerings Remain Competitive And Relevant In The Market. Skill Requirements 1. Expert Knowledge Of Medical Device Regulation (Mdr) And Associated Compliance Frameworks Such As Iso 13485. 2. Excellent Problem-Solving Skills And Ability To Design Regulatory-Compliant Solutions. 3. Strong Understanding Of Product Development Processes In The Medical Device Industry. 4. Proficiency In Conducting Training, Mentorship, And Team Development Activities. 5. Exceptional Analytical Skills To Evaluate Market Trends And Client Specifications Effectively. Other Requirements 1. Optional But Valuable Certifications: Certified Quality Auditor (Cqa), Regulatory Affairs Certification (Rac), Iso 13485 Lead Auditor Certification. Maximum Salary (US): 192000 Minimum Salary (US): 95000 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 223,000 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 June 2026 totaled $14.8 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. Disclaimer Privacy Statement Terms of use Sitemap Raise a Grievance We use cookies on our site. Please read more about cookies policy here. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Opens in a new tab. Copyright © 2026 HCL Technologies Limited Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. 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