Senior Regulatory Affairs Lead, MedTech - Hybrid

Fresenius Kabi USA; Lake Zurich (IL); Hybrid; USD 160,000 - 170,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Paid time off

Job summary

Fresenius Kabi USA in Lake Zurich, IL, seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making for complex products, guiding execution and mentoring teammates. The role ensures lifecycle compliance and acts as the senior regulatory lead on cross-functional teams.

Onsite 3 days per week with some remote work, the position collaborates with regulatory agencies to align strategies with business objectives and drive successful submissions and audits.

Qualifications

• Bachelor's degree with 8+ years in a regulatory function.
• Strong technical, regulatory, and problem-solving skills.
• Experience with complex regulatory strategies and challenges.
• Proven collaboration with regulatory agencies.

Responsibilities

• Own regulatory decision-making and strategy for highly complex initiatives.
• Prepare and coordinate U.S. and international submissions (510(k)/NDA where applicable).
• Approve strategies and represent Regulatory on cross-functional teams.
• Maintain communications across Regulatory and project teams to ensure alignment.

Skills

Regulatory strategy

Regulatory decision making

Stakeholder influence

Cross-functional collaboration

Education

Bachelor's degree

Job description

Fresenius Kabi USA in Lake Zurich, IL, seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making for complex products, guiding execution and mentoring teammates. The role ensures lifecycle compliance and acts as the senior regulatory lead on cross-functional teams.

Onsite 3 days per week with some remote work, the position collaborates with regulatory agencies to align strategies with business objectives and drive successful submissions and audits.