- Provide regulatory input to product lifecycle planning and new product development mainly forsurgicallights
- Act as Global Regulatory Lead for surgical lights and work with Country Regulatory colleagues for international registrations of the surgical lights.
- Ensure compliance with regulations (21 CFR 820, MDR), standards (ISO 13485, product specific standards), and the qualitymanual
- Work closely with product development, clinical, qualityand marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance)
- Create GSPRC, STEDs and review TD documents, including Clinical Evaluation reports, labeling, advertising, promotion and marketing literature
- Monitor international applications;communicate the progress to internal stakeholders
- Ensure compliance with product post-marketing approval requirements
- Support change control activities
- Provide MDR updates/guidance to product development teams
- Completed academic education in a related medical, scientific, engineering services, or regulatory discipline isrequired
- Minimum of 3 years' experience in creating and managing international regulatory submissions for Medical Devices (Active medical devices of Class I & II preferred)
- Global registration experience for medical devices, limited experience with US 510(k) submission and experience in reviewing technical documents, Project Management skills and experience, ideally with supporting new product developments and launches
- Strong proficiency with Microsoft systems (Excel, PowerPoint, and Word and Teams)
- Strong attention to detail as well as strong questioning and listening skills
- Good planning and organizational skills
- Strong internal customer service orientation with "do whatever it takes" attitude
- Excellent English communication skills are mandatory; good German knowledge is a plus
- Ability to work in cross-functional teams with people from various disciplines and cultures
- Competitive total compensation package
- Professional development opportunities
- High importance placed on work life balance
- Commitment to growing and developing an inclusive and diverse workforce
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Regulatory Affairs Specialist - Munich, Deutschland - Baxter
Beschreibung
This is where you save and sustain lives
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 the home. 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.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
For our business division Baxter Medical Systems we are currently looking for a Regulatory Affairs Specialist – Medical Devices (m/f/d) based in Munich, Germany.
Your tasks:
Your profile:
What are some of the benefits of working at Baxter?
