Regulatory Affairs Specialist
vor 6 Monaten
**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.
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.
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:
- Provide regulatory input to product lifecycle planning and new product development mainly for surgical lights
- 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 quality manual
- Work closely with product development, clinical, quality and 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
- Ensure compliance with product post-marketing approval requirements
- Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary)
- Support change control activities
- Provide MDR updates/guidance to product development teams
Your profile:
- Completed academic education in a related medical, scientific, engineering services, or regulatory discipline is required
- 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
**What are some of **the **benefits of working at Baxter?**:
- Competitive total compensation package
- Professional development opportunities
- High importance placed on work life balance
- Commitment to growing and developing an inclusive and diverse workforce
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
- Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mi_ssion._
- #IND-DACH_
**Reasonable Accommodations**
**Recruitment Fraud Notice**
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review o
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