Sr Manager, Regulatory Affairs at Baxter International

Deerfield, Illinois, United States

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$104,000 – $143,000Compensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

NoVisa

Healthcare, Medical DevicesIndustries

Requirements

Experience with regulatory compliance activities surrounding EU MDR, EUDAMED, GUDID, UDI, SPL, and other requirements across various jurisdictions in the world
Authorized to work for any employer in the U.S. (no sponsorship available)
Relevant skills/experience influencing salary within $104,000 to $143,000 base range

Responsibilities

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 of initiatives
Facilitates cross-functional cooperation with marketing, legal, regulatory affairs, quality, supply chain, manufacturing, labeling, purchasing, and division PMOs to develop and achieve results
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 projects
Serves as a champion of product lifecycle management processes
Leads teams to execute product submissions and participates on cross-functional teams, collaborating 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, including new products and maintenance of licenses/authorizations for existing marketed products
Identifies and prioritizes key areas of risk, and develops and implements appropriate mitigation plans
Establishes appropriate communication within RA, with Marketing, and with other functions primarily at project level, favoring proactive communication
Ensures regulatory strategy and deliverables are aligned with project teams and business objectives
Leads regulatory activities related to portfolio of products
Develops and documents sound regulatory decisions and justification
Leads team in defining strategies
Provides clear direction on product lifecycle management requirements

Skills

Regulatory Affairs

Business Leadership

Technical Leadership

Project Execution

Compliance

Strategic Planning

Cross-functional Collaboration

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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