Sr Manager, Regulatory Affairs

Found in: Careerbuilder One Red US C2 - 2 weeks ago

Plymouth MN United States BAXTER Full time

Vantive: A New Company Built On Our Legacy

 

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

 

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

 

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your Role at Baxter
 

Responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations for products for a global business unit with focus on electromechanical devices.

Functional team lead electromechanical

What you'll be doing
• Provide technical and strategic input for regulatory decisions aligned with business strategy  
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups  
• Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards  
• Assess impact of new regulations and provide feedback.  
• Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks  
• May act as primary contact for meetings with regulatory authorities including planning and leadership  
• Maintain appropriate communication within the RA function, with GBU Marketing, and with other functions primarily at the project team level  
• Plan and manage complex projects and prioritize workload  
• Initiate, manage and maintain operational activities in support of new and existing marketing authorizations  
• May manage regulatory budget at project level  
• May represent Baxter interests in industry and working groups  
• Set team, group, or service objectives to assure they align with the regulatory strategy  
• May provide direct supervision of individuals including mentoring, performance management and staffing decisions​ 

What you'll bring
• Bachelor’s degree or country equivalent in a scientific discipline  
• Masters and/or PhD is preferred   
• Minimum of 7-year experience in Regulatory Affairs space or related fields
• Ability to work effectively in multinational/multicultural environment  
• Management skills  
• Technical skills  
• Expert Regulatory knowledge in electromechanical devices 
• Sound basis of Scientific (Training/ Communications) knowledge  
• Ability to oversee multiple projects in a matrix team environment  
• Excellent oral and written communication and presentation skills  
• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities  
• Ability to lead, coach, and motivate others  
• Ability to accomplish results through others​ 

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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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 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.

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