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

Job Summary

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.