Sr Manager, Regulatory Affairs

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.

Provides business, execution and technical leadership for major, high-complexity efforts (top corporate initiatives) within the Baxter regulatory organization while leading multiple teams through all phases initiatives. The Sr. Manager facilitates cross functional cooperation to achieve results and collaborates with marketing, legal, regulatory affairs, quality, supply chain, manufacturing, labeling, purchasing, and division PMOs to develop and achieve results. This person will interact with, and influence senior internal and external collaborators including regulatory authorities. The Sr. Manager will make launch date commitments to businesses and manage partner expectations with regard to Baxter deliverables during the project. The selected individual will act as an advocate for product lifecycle management processes.

• Experience with regulatory compliance activities surrounding EU MDR, EUDAMED, GUDID, UDI, SPL, and other requirements across various jurisdictions in the world.
• Leading teams to implement product submissions.
• Participate on cross-functional teams and collaborating on innovative strategies for accelerating time to market and regulatory approvals.
• Monitor and assess impact of new regulations and provide input to draft regulations and guidance. Mentor and coach teams and to support business units on various regulatory initiatives.
• Develops and implements regulatory plans aligned with business strategy for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products
• Identifies and prioritizes key areas of risk, and develop & implement appropriate mitigation plans
• Establishes appropriate communication within RA, with Marketing, and with other functions primarily at project level and favor proactive communication
• Ensures regulatory strategy and results are aligned with project teams and business objectives
• Leads regulatory activities related to their portfolio of products
• Develops and documents sound regulatory decisions and justification
• Leads team in defining strategies
• Provides clear direction on product lifecycle management requirements to meet expectations of external customers and business partners
• Interacts through updates and reviews with all functions and levels of management ensuring effective ongoing communications across teams and partners
• Ensures identification and communication of risks, development of risk plan and proactive management of risk response strategies
• Foresees potential conflict scenarios for proactive resolutions and handles conflict situations to achieve mutually beneficial results
• Works closely with business collaborators to understand business difficulties and helps identify business solutions and/or capabilities required to address specific business challenges
• Improves business results through continuous improvement in organization's ability to implement

• Minimum MBA/MS or bachelor's with equivalent plus 10-15 years' experience and 5 years of regulatory related experience with demonstrated success leading multi-site, global or enterprise-wide initiatives in the medical products industry.
• Experience in regulatory affairs
• Strong Business acumen
• Role model of Vital Behaviors and Leadership Essentials
• Strong leadership skills
• Medical device industry and/or regulatory compliance work experience a plus

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 to $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. 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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.

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