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Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Summary

The Regulatory Affairs Specialist is responsible for the global coordination and the preparation of documents/packages for regulatory submissions for Welch Allyn’s Physical Assessment and diagnostics portfolio. In this position you will also review and evaluate technical and scientific data and reports required for global submissions.

Duties and Responsibilities:

• Responsible for maintenance and global expansion of Welch Allyn’s Physical Assessment and Diagnostic product lines.

• Responsible and accountable for all operational aspects of regulatory submissions providing planning and technical support for Baxter’s products for one or more business units.

• Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards.

• Compile, edit, and proofread regulatory documents for submission under supervision and track status and progress of regulatory submission.

• Provide technical and strategic input for regulatory decisions.

• Assess impact of new regulations and provide feedback.

• Maintain regulatory files in a format consistent with requirements

• Participate as an active team member of project teams as required

• Assist in preparation and review of labeling, SOP’s, and other departmental documents

• Plan and manage complex projects and prioritize workload.

Qualifications:

• Bachelor’s degree or country equivalent in a relevant scientific discipline

• 2+ years of experience working with medical devices and its associated regulations (preferred)

• 2+ years of experience in regulatory preferred

• Ability to manage complex projects and timelines in a matrix team environment

• Scientific knowledge

• Administrative and project management skills

• Ability to multitask and prioritize

• Interpersonal and communication skills

• Technical system skills (e.g. word processing, spreadsheets, databases, online research)

• Proofreading and editing skills

We are open to this person working remotely with the exception of those that reside in the state of Colorado or New York City.

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The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.

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