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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.
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.
What You'll Be Doing
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.
What You'll Bring
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
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.
We understand compensation is an important factor as you consider the next step in your career.At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices.To that end, this position has a salary range of $64,000-$88,0 and also includes an annual incentive bonus. The above range represents the expected salary range for this position.The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location
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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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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 here and let us know the nature of your request along with your contact information.
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Hillrom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity. Please click https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf To view the EEO is the Law poster.