Operations Manager - Compliance at Siemens Healthineers
Cleveland, OH 44106, USA -
Full Time


Start Date

Immediate

Expiry Date

13 Nov, 25

Salary

138000.0

Posted On

13 Aug, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Compliance Software, Audit Management, Iso Standards

Industry

Pharmaceuticals

Description

ABOUT SIEMENS HEALTHINEERS

At Siemens Healthineers, we are committed to pioneering breakthroughs in healthcare for everyone, everywhere. As a global leader in medical technology and diagnostics, we’re driven by innovation, purpose, and a shared mission to improve patient outcomes and care efficiency. Our growing U.S. team is at the forefront of healthcare transformation—and we invite you to join us.

POSITION SUMMARY

We are seeking a detail-oriented and proactive Operations Manager – Compliance to oversee and enhance compliance operations across our U.S. business units. This hybrid role involves on-site leadership combined with office collaboration to ensure regulatory adherence, risk mitigation, and continuous improvement within a highly regulated healthcare environment. You will lead cross-functional teams to drive compliance excellence and support operational integrity.

QUALIFICATIONS

  • Bachelor’s degree in Business, Healthcare Administration, Compliance, or related field
  • 5+ years of experience in compliance, quality assurance, or regulatory affairs, preferably in healthcare or med-tech
  • Strong knowledge of FDA regulations, ISO standards, and healthcare compliance frameworks
  • Excellent leadership and communication skills with experience managing hybrid teams
  • Ability to analyze complex regulations and apply practical solutions
  • Familiarity with audit management and compliance software a plus
  • Must be legally authorized to work in the United States
  • Must be available for a hybrid work schedule (on-site and in-office presence required)

How To Apply:

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Responsibilities
  • Develop, implement, and oversee compliance programs aligned with FDA, ISO, and other applicable regulations
  • Monitor compliance risks and conduct audits, investigations, and corrective action plans
  • Partner with quality, legal, and operational teams to ensure adherence to regulatory requirements
  • Manage reporting processes and maintain documentation for internal and external audits
  • Lead training initiatives to promote compliance awareness across departments
  • Analyze compliance data and recommend process improvements to mitigate risks
  • Foster a culture of ethical behavior and regulatory adherence throughout the organization
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