Job Summary

The Senior Technical Architect in MDR plays a pivotal role in designing and implementing complex technical solutions within the medical device regulatory landscape. This role is crucial for ensuring that solutions align with business objectives, meet regulatory standards, and adhere to industry best practices. The Senior Technical Architect will leverage their extensive knowledge to guide the development of innovative, scalable, and secure solutions that address client needs and drive organizational success.

Key Responsibilities

1. Design And Architect Large-Scale Medical Device Regulatory (Mdr) Solutions, Ensuring Compliance With Regulatory Requirements And Focusing On Scalability, Performance, And Security.
2. Provide Technical Leadership And Mentorship To The Team, Empowering Them With The Necessary Skills And Knowledge In Mdr Processes And Technology To Enhance Delivery Capabilities And Mitigate Risks.
3. Continuously Research And Upskill In Emerging Technologies Related To Mdr, Ensuring The Development Of High-Quality, Future-Proof Solutions That Meet Client Expectations And Comply With Industry Standards.
4. Leverage Extensive Domain Knowledge And Technical Expertise To Gather Client Requirements, Deliver Tailored Solutions, And Develop A Comprehensive Technology Strategy Aligned With Business Goals And Regulatory Frameworks.
5. Collaborate With Cross-Functional Teams To Ensure Successful Implementation Of Mdr Solutions, Maintaining Compliance With Iso 13485 And Providing Guidance On 510(K) Submissions And Related Documentation.

Skill Requirements

1. Expert Knowledge Of Medical Device Regulation (Mdr) And Related Compliance Frameworks.
2. Strong Proficiency In Architectural Design Principles And Methodologies For Large-Scale Technical Solutions.
3. Excellent Understanding Of Iso 13485 Standards And Experience With 510(K) And Ivdr Processes.
4. In-Depth Knowledge Of Remediation Processes And The Ability To Integrate These Into Technical Solutions.
5. Proven Ability To Lead And Mentor Teams, Fostering Skills Development In Mdr Technologies.

Other Requirements

1. Optional But Valuable Certifications: Certified Information Systems Security Professional (Cissp), Iso 13485 Lead Auditor, Or Relevant Certifications In Medical Device Quality Management Systems.