Quality System Regulatory Affairs Specialist APJ at Danaher Corporation

Singapore, Singapore, Singapore

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, Medical DevicesIndustries

Requirements

Minimum 2-3 years proven QMS and/or RA experience in the Regulated Industry
International experience in problem solving, complaint handling or equivalent
BSc degree or equivalent in science, engineering or equivalent
Travel Requirements: 25%

Responsibilities

Maintain the existing Quality Management System (QMS) according to standards (ISO13485, ISO9001, ISO14001) and applicable regulatory requirements for Leica Microsystems Commercial Offices in APJ region
Support the APJ functional commercial (CO) teams to maintain compliance with the QMS processes, interact directly with 3rd party auditors during site assessments, provide overall leadership to the functional levels and support for all regulatory and quality assurance (RA/QA) related issues at CO side
Make recommendations for the continuous improvement of QMS processes and direct resources in support of Key Performance Indicators (KPI) and other metrics
Verify effectiveness of QMS by internal audits
Manage the QMS platform for creation of quality documents and quality trainings
Responsible for product registration activities in APJ region where required; maintain a positive relationship with relevant government and regulatory authorities; support the APJ regulatory team in their registration activities
Coordinate post market surveillance (PMS) activities like adverse event/complaint, recall/field corrective actions in cooperation with the respective Business Units
Validate processes impacting on the QMS as needed

Skills

ISO13485

ISO9001

ISO14001

Quality Management System

QMS

Regulatory Affairs

Compliance

RA/QA

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.

Land your dream remote job 3x faster with AI

Try Jobo Free