Senior Regulatory Affairs Manager, US — Onsite Leader

RAPS Institute; Englewood (CO); On-site; USD 120,000 - 175,000; Full time

Job summary

Zimmer Biomet is seeking a Senior Manager of Regulatory Affairs, Domestic, to lead the US regulatory footprint. You will manage and mentor a team of regulatory professionals, craft strategic approvals, and collaborate with cross-functional partners to drive submissions from concept to commercialization.

The role requires onsite presence in Englewood, Colorado, 3–5 days per week, with a strong focus on FDA pathways, ISO 13485 compliance, and regulatory strategy execution in a fast-paced medical

Qualifications

• Bachelor’s degree and at least 7 years of relevant experience.
• Experience with orthopedic devices is a plus.
• RAC credential is a plus.
• Strong familiarity with US FDA requirements and ISO 13485:2016.

Responsibilities

• Review and approve regulatory strategy proposals.
• Oversee regulatory applications and submissions.
• Establish regulatory schedules aligned with timelines and budgets.
• Maintain documentation and systems (e.g., FDA pathways, GUDID) and ensure timely updates.
• Mentor and grow the Domestic regulatory team.
• Collaborate with leadership to prioritize regulatory work across departments.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

Time management

Regulatory knowledge

Education

Bachelor’s degree in technical/scientific field

RAC credential

Job description

Zimmer Biomet is seeking a Senior Manager of Regulatory Affairs, Domestic, to lead the US regulatory footprint. You will manage and mentor a team of regulatory professionals, craft strategic approvals, and collaborate with cross-functional partners to drive submissions from concept to commercialization.

The role requires onsite presence in Englewood, Colorado, 3–5 days per week, with a strong focus on FDA pathways, ISO 13485 compliance, and regulatory strategy execution in a fast-paced medical