Prentke Romich GmbH

Compliance

• Manage regulatory submissions, registrations, renewals, and related documentation for domestic and international markets.
• Provide regulatory guidance for product development, manufacturing, labeling, marketing, distribution, and market expansion activities.
• Create, maintain, and support technical documentation, product registrations, Declarations of Conformity, and regulatory files.
• Review product changes, labeling, marketing materials, and documentation for regulatory compliance.
• Monitor regulatory changes, assess business impact, and recommend process improvements.
• Represent Regulatory Affairs on project teams and provide regulatory expertise across the organization.
• Support risk assessments, product recalls, medical device reporting activities, and regulatory audits as needed.

Regulatory Affairs Specialist

Project Manager

• Lead cross-functional projects from initiation through completion
• Ensure alignment across scope, timelines, budgets, and quality standards
• Proactively manage risks and drive problem-solving
• Plan, execute, and close projects against defined objectives
• Develop and manage project plans covering scope, schedule, budget, resources, and risks
• Assemble and guide cross-functional teams, fostering collaboration and accountability
• Monitor project performance and address risks, issues, and changes
• Manage stakeholder communication throughout the project lifecycle