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Job Description
Structured overview of role & requirementsAbout This Role
Manage and drive Change Requests and Change Orders to closure, ensuring product configuration and document control accuracy in PLM and SAP systems.
Ensure compliance with GMP, GDP, FDA, and ISO standards while performing data quality reviews and risk assessments to maintain data integrity.
Support digital transformation efforts using AI, automation, analytics, and collaborate with cross-functional teams for continuous process improvement.
Minimum Requirements
Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field.
5-8 years of experience in PLM, Change Management, Master Data Management, Configuration Management, or Document Control within regulated MedTech, Biotechnology, or Life Sciences sectors.
Experience with PLM platforms (e.g., Teamcenter, Windchill, Agile PLM, Enovia, Arena) and SAP.
Must comply with regulatory standards including FDA 21 CFR Parts 11, 820, and 809, ISO 13485, GMP, GDP, and Change Control processes.
Ideal Candidate Profile
Experienced in leveraging digital tools and AI-enabled solutions for process optimization in product lifecycle and master data management.
Strong analytical and stakeholder management skills demonstrated through collaboration with R&D, Quality, Manufacturing, Regulatory, Supply Chain, and IT.
Proven track record in regulated environments with expertise in configuration management and regulatory compliance within MedTech or Life Sciences domains.