Sr Manager, Regulatory Affairs

Baxter International Inc. • Deerfield, IL

138d • $104,000 - $143,000

About The Position

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. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

Requirements

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

Nice To Haves

• Role model of Vital Behaviors and Leadership Essentials.
• Business acumen.

Responsibilities

• Provides business, execution and technical leadership for major, high-complexity efforts within the Baxter regulatory organization.
• Facilitates cross functional cooperation to achieve results and collaborates with marketing, legal, regulatory affairs, quality, supply chain, manufacturing, labeling, purchasing, and division PMOs.
• Interacts with and influences senior internal and external stakeholders including regulatory authorities.
• Makes launch date commitments to businesses and manages stakeholder expectations regarding Baxter deliverables during the project.
• Serves as a champion of product lifecycle management processes.
• Leads teams to execute product submissions.
• Participates on cross-functional teams and collaborates on innovative strategies for accelerating time to market and regulatory approvals.
• Monitors and assesses impact of new regulations and provides input to draft regulations and guidance.
• Mentors and coaches teams to support business units on various regulatory initiatives.
• Develops and executes regulatory plans aligned with business strategy for complex projects.
• Identifies and prioritizes key areas of risk, and develops & implements appropriate mitigation plans.
• Establishes appropriate communication within RA, with Marketing, and with other functions primarily at project level.
• Ensures regulatory strategy and deliverables 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.
• Provides clear direction on product lifecycle management requirements.
• Ensures identification and communication of risks, development of risk plan and proactive management of risk response strategies.
• Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes.
• Works closely with business stakeholders to understand business pain points and helps identify business solutions.

Benefits

• Medical and dental coverage that start on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees