Specialist, Commercial Quality and Regulatory Affairs at Danaher Corporation

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s degree in pharmacy, biology, biomedical engineering or chemistry
Experience >3 years in regulatory affairs and quality assurance
Knowledge in Mexico and other LATAM countries medical device regulations
English language (basic) to read documents and communicate with global organization
Experience with Quality Management Systems and GMP regulation

Responsibilities

Prepare the technical dossiers to support registration for new products and license renewals and support Field Actions and other post market vigilance activities
Evaluate design changes against regulatory requirements to support the modifications in the registration license and organize a database of legal documents for tenders and internal regulatory processes
Support our Sales Channel Partners by providing the technical documentation for their regulatory submissions
Review and ensure that the Quality Management System is up to date and aligned with current sanitary regulations
Support warehouse GMP oversight and processes improvements by taking part in the internal quality audits, external sanitary agency audits, suppliers and distributors audits

Skills

Regulatory Affairs

Quality Management

Product Registration

Post Market Vigilance

Legal Documents

Technical Documents

Customer Complaints

Quality Management System

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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