Manager, Quality and Regulatory Affairs at Danaher Corporation

Seoul, South Korea, South Korea

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, Medical DevicesIndustries

Requirements

Bachelor’s degree in Natural Science, Engineering, Medicine, or equivalent field
6 years of experience in quality management/regulatory affairs at a medical device or in vitro diagnostic medical device manufacturing/import company
Experience in maintaining quality management systems to align with local regulations, ISO 13485, and good distribution practices
Understanding of Medical Device Act and In Vitro Diagnostic Devices Act regarding medical device import
Ability to communicate fluently in Korean and English

Responsibilities

Ensure compliance of the local team and global QMS to new and updated quality and regulatory standards and regulations
Provide training to the local team as necessary to ensure medical devices are imported and released in alignment with market regulatory requirements
Collaborate with global, cross-functional teams in completing complaint investigations, adverse event reporting, field corrective actions/recalls, and geographic expansion efforts
Maintain the import business license with the regional office of the Ministry of Food and Drug Safety (MFDS) and lead device registrations and renewals in South Korea
Act as the Quality Officer for SCIEX in South Korea

Skills

Quality Management System

Regulatory Compliance

Medical Device Regulations

Adverse Event Reporting

Complaint Investigations

QMS Training

Market Approval

Regulatory Affairs

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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