Job Description :
Drive global regulatory strategy regarding UDI and Serialization as well as product label(s) and labeling to sustainably support the global registration and ongoing compliance throughout the life cycle of medical device product(s).
In collaboration with cross functional teams, will be responsible for driving global device labeling and UDI initiatives into strategic business and project objectives.
•Develop and communicate Global UDI requirements and provide ongoing global regulatory labeling strategies and plans for complex UDI implementation programs as well as new product development. Integrate key labeling requirements and best practices into global UDI and labeling strategies.
•Help formulate and drive global UDI initiatives as well as global labeling traceability requirements within project and product teams.
•Represent or lead the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.
•Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects..
•Effectively assess impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
•Effectively perform gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications.
•Establish appropriate cross-functional partnerships within RA and other functions to drive key global labeling strategies and initiatives.
•Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
•May provide direct supervision of individuals
1.Sound basis of global regulatory knowledge. Expert device labeling requirements and implementation will be an advantage.
2.Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills.
3.Strong oral and written communication and presentation skills
4.Demonstrated interpersonal skills including strong negotiation and facilitation skills
5.Ability to independently identify compliance risks and escalate when necessary
6.Ability to lead and coach others
7.Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5-7 years regulatory experience in RA or related field, including managing people or projects. Direct experience with global device labeling will be an advantage.
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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Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
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