Sterilization Subject Matter Expert (m/f/d)

About the Role

As a Sterilization Subject Matter Expert at Medevio, you will play a key role in supporting global development projects and our clients across the full medical device lifecycle by planning and managing the sterilization activities for our products in collaboration with the external sterilization providers, including full sterilization validations and product adoptions. You will collaborate closely with internal cross-functional teams including Product Development, Operations, Quality, and Regulatory Affairs, but also external sterilization providers and our customers, ensuring sterilization strategies are aligned with project goals and regulatory requirements.

The following challenges await you:

• Lead sterilization activities for Medevio projects and clients worldwide, covering the entire medical device lifecycle.
• Develop effective sterilization strategies based on customer, product and regulatory requirements with a high focus on EO sterilization.
• Collaborate with internal stakeholders and customers to align on timelines and deliverables.
• Assess sterilization needs for new products, changes, and projects, and ensure the maintenance of the active sterilization validations as legally required.
• Coordinate with external partners such as sterilization service providers and test laboratories, including sample management, quotation processes, and critical review of protocols and reports.
• Maintain up-to-date knowledge of global medical device regulations, particularly ISO 11135, and apply emerging standards and methodologies in sterilization, ensuring the implementation of regulatory requirements related to the sterilization of medical devices.

Your profile:

• Bachelor’s or Master’s degree in Engineering (preferably Biomedical, Mechanical, Natural Sciences, Biotechnology or Chemistry).
• Minimum of 5 years of relevant experience in medical device sterilization validation, especially on EO sterilization.
• Strong knowledge of applicable standards and regulations, including ISO 11135, ISO 13485, FDA regulations, and GMP.
• Proven ability to manage and execute multiple projects simultaneously.
• Capable of working both independently and collaboratively with minimal supervision.
• Excellent problem-solving and interpersonal skills; able to communicate effectively across all organizational levels.
• Documented sterilization training by a recognized third party or equivalent internal training by a subject-matter expert.
• Ability to travel up to 25% of the time, both domestic and international.

ReqID: 58107 #J-18808-Ljbffr