Senior Manager, Customer Regulatory Support at Danaher Corporation

Marlborough, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, BiotechnologyIndustries

Requirements

Bachelor’s degree in a science/engineering or related field required, advanced degree beneficial
Minimum 5-7 years’ experience in product management, product support, or quality in a life sciences company
Understanding of relevant regulatory, quality and scientific fundamentals applicable to Bioprocess products
Demonstrated ability to balance resources, timing and quality of outcomes
Proven leadership and change management skills
Driven with experience leading cross-functional activities across global teams
Strong written and verbal communication skills, fluent in English
Ability to travel – opportunities for occasional international travel

Responsibilities

Lead direct reports to set and maintain standards, and in providing customer facing regulatory support documentation, including change control notifications (CCNs), ensuring customer satisfaction and protection of Cytiva Intellectual Property
Provide guidance to other relevant Cytiva functions regarding customer expectations and required information and standards
Lead and set the direction for the team, individual contributors and direct reports
Contribute to the strategy and operational plan for the department in close collaboration with other critical functions in Cytiva
Develop people, organization, and operating mechanisms to successfully meet customer expectations and requirements of Cytiva internal stakeholders
Identify and lead cross functional activities, including developing internal and external documentation to align with industry developments and enhanced customer expectations
Guide direct reports and the business in a global environment to set the strategy and operational approach for Cytiva
Lead a team that is providing guidance to other Cytiva functions and associates involved in product development, lifecycle management, manufacturing, and quality assurance regarding applicable customer regulatory requirements and customer expectations on products, processes, and documentation to ensure market access for Cytiva products

Skills

Regulatory Compliance

Customer Regulatory Support

Product Development

Lifecycle Management

Manufacturing

Quality Assurance

Global Regulatory Strategy

Team Leadership

Market Access

QARA

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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