Quality and Regulatory Support Manager at Danaher Corporation

Marlborough, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, DiagnosticsIndustries

Requirements

Bachelor of Science degree in Biochemistry/Chemistry or related field
3+ years of experience in GMP, quality, product management or a related field
Understanding of quality and regulatory requirements in the Bioprocess industry
Driven with experience leading cross-functional activities across global teams
Strong written and verbal communication skills, fluent in English

Responsibilities

Support the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory and technical-related information as it pertains to Bioprocess filtration products
Identify and lead cross functional activities, including creating/updating internal and external documentation to align with industry developments and enhanced customer expectations
Function as the regulatory support expert and discussion partner to R&D, QA, Product Management and other functions, and facilitate risk-based decisions
Prepare, update and review regulatory support documentation, including Validation Guides, statements, certificates and other regulatory related documentation for new and existing products
Participate in change control activities and risk assessments, writing change notifications, developing notification qualification packages, and releasing to customers
Respond efficiently and promptly to customers' regulatory based questions and requests, which will include investigations, preparations and delivery of statements and documentation, use of internal and external databases

Skills

Quality Management

Regulatory Compliance

Bioprocess

Filtration Products

New Product Development

Change Control

Technical Documentation

Life Sciences

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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