[Hiring] Regulatory Affairs Specialist @Baxter International Inc.

Role Description

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.

• 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.

Qualifications

• 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 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, Copilot).
• 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.
• Ability to work in cross-functional teams with people from various disciplines and cultures.
• Review technical documents.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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.