Regulatory Affairs Specialist - Medical Devices (m/f/d)
Req # JR - 127423 Location München, Bavaria, Germany Job Category Regulatory Affairs Date posted 04/02/2024This 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 Systemswe are currently looking for a Regulatory AffairsSpecialist – Medical Devices (m/f/d) based in Munich, Germany.
Your tasks:
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
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 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
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
If you are keen to understand more about the prospect of the above role, please apply here, so we can discuss it with you in more detail.
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 thelinkhere and let us know the nature of your request along with your contact information.
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 ourRecruitment Fraud Notice.
For further information, please reach out to Mr Sebastian Lange via E-Mail: sebastian_lange@baxter.com
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 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
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.
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