Senior Specialist (m/f/d) – Quality Assurance / Regulatory Affairs – temporary 2 years

Overview

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role

As Senior Specialist (m/f/d) – Quality Assurance / Regulatory Affairs you are responsible for the local implementation of regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of the products. Support regulatory activities relating to specific portfolio of Kidney Care (chronic and acute) products/projects. You are responsible for the maintenance of Quality Management System and related documentation, ensuring the quality compliance of commercialization, distribution, and local supplier quality management.

This role is based in Unterschleissheim near Munich (hybrid option).

What you'll be doing

• Implement and execute regulatory strategies for Medicinal Products and Medical devices
• Identify and elevate key areas of regulatory risk
• Monitor evolving regulatory requirements and ensure compliance with internal and external standards
• Collaborate closely with cross-functional teams to align regulatory plan with project and business goals
• Serve as the primary point of contact with local regulatory authorities
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements (New MAAs, Variations, Renewals etc.)
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements

• Implement and maintain the local Quality System, Support QA related processes
• NCR and CAPA activities and timely implementation
• Change Control activities
• Timely implementation of Field Actions (FA)
• Local activities for Supplier qualification and management
• Local documentation (SOPs, periodic reviews, implement global documentation at local level)
• Support preparation and execution of Quality/Management Reviews
• Perform Customer Eligibility checks (Customer and Supplier Approvals)
• Support Internal audit program planning and execution
• Ensure readiness to External audits for assigned quality system
• Interact with authority or certification body for assigned quality systems

• Support Distribution operations
• Carry out transactions in the Enterprise Resource Planning (ERP) JDE to ensure adequate inventory control, traceability, tracking and release of goods
• Disposition of returned, rejected, recalled or falsified products
• Back Up for Responsible Person for Wholesaling Activities
• Back Up for Comissioneer of graduated plan for non-medical risks
• Support Tender Management
• Liaison with country functions and Third Party Logistic provider in day-by-bay activities or specific projects

What you'll bring

• Bachelor’s degree in scientific discipline
• 2-4 years regulatory, quality, or equivalent experience within a pharmaceutical and/or medical device company, CRO, CMO or similar organization
• Knowledge of regulations, Good Manufacturing Practices, Distribution Practices and ISO standards
• Scientific knowledge
• Project management skills
• Manage multiple deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and escalate when necessary
• Fluency in German and English

Have we sparked your interest?

If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply directly on our Online System.

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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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