Lead Auditor - Sterilization & MDR/IVDR (Remote)

Work From Anywhere; United Kingdom; Remote; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Flexible schedule

Training opportunities

Global team

Job summary

SGS is seeking a senior Technical Manager – Sterilization within medical devices to lead the Sterilization team across global delivery. This remote role reports to the Head of Delivery & Operations and requires deep expertise in sterilization, MDR/IVDR, and regulatory review.

You will drive QMS development, training, and cross‑functional collaboration, ensuring compliance with MDCG guidance and NB 1639. A proven track record in leading global teams and advancing process improvements is essential.

Qualifications

• 10+ years in medical device industry with sterilization experience.
• 5+ years MDR/IVDR lead auditor or product assessor – Sterilization.
• 2+ years in a leadership role with cross-functional teams.
• Experience developing training and qualification programs.

Responsibilities

• Oversee sterilization processes and provide technical support across schemes.
• Lead MDR Product Assessors-Sterilization team and auditors.
• Develop and maintain sterilization QMS documentation.
• Manage resource planning, capacity, and performance metrics.
• Provide training and regulatory guidance to staff.

Skills

Sterilization knowledge

Medical device compliance

Team leadership

Regulatory guidance

Technical communication

Education

University degree in microbiology/engineering or related field

Job description

SGS is seeking a senior Technical Manager – Sterilization within medical devices to lead the Sterilization team across global delivery. This remote role reports to the Head of Delivery & Operations and requires deep expertise in sterilization, MDR/IVDR, and regulatory review.

You will drive QMS development, training, and cross‑functional collaboration, ensuring compliance with MDCG guidance and NB 1639. A proven track record in leading global teams and advancing process improvements is essential.