At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics, and in homes. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful, and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Senior Specialist (f/m/d) Regulatory Affairs EMEA
We are currently seeking a Senior Specialist (f/m/d) Regulatory Affairs EMEA based in Opfikon, Zurich. To strengthen our CQA & RA team, we invite you to explore this exciting opportunity.
Your Responsibilities:
Order Swissmedic Free Sales Certificates (FSCs) via the Swissmedic portal.
Handle notarizations/legalizations of regulatory and quality documentation and FSC certificates.
Organize signoffs of quality and regulatory documentation.
Compile and submit regulatory documents according to regulatory requirements.
Support regulatory activities relating to a specific portfolio of products/projects.
Process invoices (Swissmedic, Notary, Consular Service, State/Federal Chancellery, etc.).
Respond to inquiries from Swiss regulatory authorities within strict timelines.
Identify and elevate key areas of regulatory risk.
Participate as an active team member and provide regulatory advice to project teams.
Provide local support for audits and quality and regulatory meetings (catering, room reservations, hotel bookings, etc.).
Set up purchase orders for projects, workshops, catering, office supplies, etc.
Manage the archive (digital/paper).
Represent or lead regulatory affairs in small project teams.
Organize and actively participate in quality and regulatory meetings, team meetings, and events in Switzerland and the EMEA region.
Handle local supplier management.
Prepare meeting content, set up agendas, ensure logistics, and follow up on action items.
Track expenses for sign-off, manage invoices, and oversee cost center budget activity.
Ensure supplier invoices are in order and that payments are processed on time.
Coordinate European project management as necessary and manage specific projects/activities from start to finish.
Gather data and produce reports in a timely and accurate manner for key senior stakeholders.
Your Profile:
Solid knowledge of a regulatory, quality, or legal environment.
Previous administrative experience in a dynamic, fast-paced international environment.
Strong organizational skills and attention to detail.
Excellent teamwork skills, proactive in suggesting ideas and solutions.
Ability to deliver speed and accuracy in tasks under strict deadlines.
Networking skills to manage complex agendas with senior executives globally.
Flexibility to manage worldwide time zone agendas.
Interest in understanding the functions of critical stakeholders.
Technology-savvy, proficient with virtual working tools and video conferencing.
Very good knowledge of MS Office applications (Excel, Word, PowerPoint) and remote meeting tools (Zoom, MS Teams, Webex, etc.).
Excellent communication skills in English and German (both written and spoken).
Our Offer:
We provide professional development opportunities to help you continuously enhance your skills and knowledge. Alongside this, we offer competitive remuneration packages to recognize and reward your contributions.
We believe in fostering a diverse and inclusive work environment where individuals from all backgrounds can thrive. We are committed to promoting diversity and consider it a true asset that enriches our organization: Diversity Commitment.
Have we sparked your interest?
If you resonate with this role and can thrive in a fast-paced working environment, we invite you to apply online using the form below. Only applications matching the job profile will be considered.
For any questions, please feel free to contact Teresa Feilhuber at Show e-mailm">.
Baxter is committed to supporting the needs for flexibility in the workplace through our flexible workplace policy, which includes a minimum of 3 days a week onsite. This policy enhances the benefits of connecting and collaborating in person in support of our Mission.
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Reasonable Accommodations
Baxter 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.
Recruitment Fraud Notice
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