This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
WHAT YOU'LL BE DOING:
- Provide regulatory input to new product development and product lifecycle planning mainly for Global Surgical Solutions product portfolio (Operating Lights, Operating Tables and Accessories)
- 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
- Monitor applications under regulatory review
- Communicate application progress to internal stakeholders
- 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
WHAT YOU'LL BRING:
- Completed academic education in a related medical, science, engineering services, or regulatory discipline required
- Minimum of 1-2 years experience in creating and managing international regulatory submissions for Medical Devices (Class I & II preferred) or more tha