Senior Specialist Commercial Quality and Regulatory Affairs (w/m/d) at Danaher Corporation

Krefeld, North-Rhine-Westphalia, Germany

Danaher Corporation Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Diagnostics, Biotechnology, Medical DevicesIndustries

Requirements

  • University degree in Science or equivalent
  • Lead Auditor certification (ISO 9001)
  • Proven experience managing a certified ISO 9001 Quality Management System
  • Strong knowledge of IVDR, environmental, and related regulations
  • Demonstrated ability to manage ambiguity, influence without authority, and drive results within a global, multi-cultural, matrixed organization
  • Excellent communication skills in German and English
  • Ability to travel for up to 20%

Responsibilities

  • Maintain, implement, and continuously improve QMS processes and infrastructure to ensure best-in-class compliance and strong business support for the Commercial organization
  • Develop, monitor, and report on key metrics to measure the performance of the Quality System
  • Drive the successful achievement of Commercial Q&RA objectives and provide regular updates on progress
  • Support the development and execution of Commercial Operations objectives for the region
  • Provide input into the EU Commercial Q&RA budget planning process

Skills

QMS
Quality Management System
Regulatory Affairs
Compliance
Environmental Compliance
Continuous Improvement

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters
1969Year Founded
IPOCompany Stage
Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries
10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.
Potential regulatory challenges in the EU for water quality sector.
Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.
The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.
Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.
Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.
Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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