**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.
**ESSENTIAL DUTIES**:
- Provide regulatory input to new product development and product lifecycle planning mainly for our **many Accessories for Operating Tables **enabling various surgical procedures
- Generation of documentation and procedures relating to product development, manufacturing, and quality control in accordance with regulatory standards
- Ensure compliance with regulations (e.g.
21 CFR 820, MDR), standards (ISO 13485), and the quality manual and internal procedures.
- Work closely with product development, clinical, 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)
- Review documents, including Clinical Evaluation reports, risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature
- Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures
- Maintain regulatory files in a format consistent with requirements
- Assess the acceptability of quality, preclinical and clinical documentation for regulatory submission filing
- Communicate preapproval compliance activities
- Ensure compliance with product post-marketing approval requirements
- Ensure external communications meet regulations
- Identify emerging issues for Regulatory Compliance
- Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary)
- Provide MDR updates/guidance to product development teams
**QUALIFICATIONS**:
- Completed academic education in a related medical, science, engineering services, or regulatory discipline required
- Minimum of 2-3 years experience in creating and managing international regulatory submissions for Medical Devices (Class I & II preferred) or more than 5 years in the medical device industry or related GMP environment or equivalent
- Specific medical device experience, particularly with Class I and Class II hardware developed devices.
- Global Registration experience with Medical Devices
- First Project Management Experience, ideally with supporting new product developments and launches
- Strong proficiency with Microsoft systems (Excel, PowerPoint, Word, Teams, Sharepoint)
- Strong attention to detail as well as strong questioning and listening skills
- Good planning and organizational skills and the ability to organize and track complex information
- Analytical and problem-solving skills
- Strong internal customer service orientation with "do whatever it takes" attitude
- Excellent English communication skills and good German knowledge are required
- Ability to work in cross-functional teams with people from various disciplines and cultures
- Review technical documents
**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.
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