Hybrid/Local Preclinical V&V Specialist

Kls Martin Lp; Jacksonville (FL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

In-house training and professional dev

Job summary

KLS Martin in Jacksonville, FL seeks a Regulatory V&V Specialist to support verification and validation activities for medical devices. The role collaborates with R&D, QA and Regulatory Affairs to ensure designs meet specifications and regulatory requirements.

Responsibilities include developing V&V tests, documenting activities, and coordinating external labs, with a focus on ISO 10993 compliance and risk assessment. Local candidates preferred within 50 miles of Jacksonville.

Qualifications

• BS degree in relevant scientific disciplines such as material science or toxicology.
• 2-4 years experience in the Medical Device Industry.
• Experience with Biocompatibility and ISO 10993 familiarity.
• Experience with FDA interactions.
• Project leadership and cross-functional collaboration.

Responsibilities

• Assist planning and documentation of V&V activities for medical devices.
• Develop V&V protocols and test plans aligned with design control.
• Collaborate across R&D, QA, Regulatory Affairs to integrate V&V.
• Support regulatory submissions with V&V documentation.
• Maintain traceability between requirements, testing, and risk analyses.

Skills

Biocompatibility

FDA interactions

Project leadership

Regulatory compliance

Education

BS degree in relevant scientific disciplines

Tools

Microsoft Office

Job description

KLS Martin in Jacksonville, FL seeks a Regulatory V&V Specialist to support verification and validation activities for medical devices. The role collaborates with R&D, QA and Regulatory Affairs to ensure designs meet specifications and regulatory requirements.

Responsibilities include developing V&V tests, documenting activities, and coordinating external labs, with a focus on ISO 10993 compliance and risk assessment. Local candidates preferred within 50 miles of Jacksonville.