Senior Specialist (f/m/d) Regulatory Affairs EMEA at Baxter

Join a Mission-Driven Organization

At Baxter, we are united by our mission to make a positive impact on people’s lives globally. Every member of our team contributes to our collective goal of improving outcomes for millions of patients, creating a shared sense of purpose that resonates throughout the organization.

Your Contributions Matter

Baxter’s innovative products and therapies are integral to healthcare systems worldwide, with a legacy of over 85 years in pioneering medical advancements. We are dedicated to creating a collaborative environment where our team members can thrive, succeed, and inspire each other. This is your opportunity to be part of a fulfilling journey dedicated to saving and sustaining lives.

Key Responsibilities

• Manage Swissmedic Free Sales Certificates (FSCs) through the Swissmedic portal.
• Handle notarizations and legalizations for regulatory and quality documentation, including FSC certificates.
• Facilitate signoffs for quality and regulatory documentation.
• Compile and submit regulatory documents in compliance with regulatory requirements.
• Support regulatory activities related to specific product portfolios and projects.
• Process invoices associated with regulatory authorities and services.
• Address inquiries from Swiss regulatory authorities while adhering to strict deadlines.
• Identify and escalate key areas of regulatory risk.
• Provide regulatory guidance to project teams as an active team member.
• Assist with audits, quality and regulatory meetings, and local administrative support.
• Set up purchase orders for various project requirements.
• Oversee the management of digital and paper archives.
• Represent or lead regulatory affairs in small project teams.
• Organize and participate in quality and regulatory meetings across Switzerland and the EMEA region.
• Manage local suppliers effectively.
• Prepare meeting agendas, logistics, and follow-up on action items.
• Monitor and process expenses, track invoices, and manage cost center budget activities.
• Coordinate European project management activities, ensuring timely follow-up on deadlines.
• Gather data and produce timely reports for senior stakeholders.

Your Profile

• Solid understanding of regulatory, quality, and legal environments.
• Administrative experience in a dynamic, fast-paced international setting.
• Exceptional organizational skills with keen attention to detail.
• Strong team player who is proactive in contributing ideas and suggestions.
• Ability to complete tasks accurately and within strict timelines.
• Networking skills to manage complex agendas with senior executives worldwide.
• Time flexibility for managing global time zone schedules.
• Interest in understanding the broader functions to effectively filter meeting and contact requests.
• Technologically proficient to facilitate virtual working and video conference tools.
• Proficient in MS Office applications and remote meeting tools (Zoom, MS Teams, Webex).
• Excellent communication skills in both English and German (written and spoken).

What We Offer

We are committed to your professional growth with opportunities for continuous skill enhancement and knowledge development. Our competitive remuneration packages reflect our recognition of your contributions. We value diversity and inclusivity in our workplace, believing that a diverse team enriches our organization.

Explore Your Potential

If this aligns with your interests and you thrive in fast-paced environments while embracing a culture of learning and growth, we invite you to join us in making a difference. Embrace the opportunity to be part of our mission-driven team, where your role is essential to the lives we touch.

Baxter fosters a flexible workplace that promotes collaboration while recognizing the importance of in-person connections. Experience the benefits of our flexible workplace policy, ensuring meaningful engagement with your colleagues.

We believe in providing reasonable accommodations for all, working towards an inclusive environment where everyone can thrive.