Senior Manager, Regulatory Affairs at Danaher Corporation

Newcastle upon Tyne, England, United Kingdom

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, Diagnostics, Life Sciences, Medical DevicesIndustries

Requirements

Bachelor’s, Master’s, or PhD in a scientific or engineering discipline
In-depth working knowledge of FDA and EU regulatory requirements for IVD devices
Extensive progressive experience supporting new product development and sustaining high-complexity diagnostic products
Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k and PMA submissions
Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets

Responsibilities

Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), PMA, EU IVDR Technical Files, STED) by defining requirements, standardizing processes, optimizing timelines, and adapting plans as needed
Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, QA, R&D, Program Management) to define and execute regulatory strategies for Leica Biosystems technologies in cancer diagnostics, IVD, and Companion Diagnostics markets
Provide regulatory input for program planning, including resource needs, budgets, and timelines, while aligning with external partners on study designs and submission strategies
Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes
Share regulatory expertise across Leica and Danaher sites, contribute to cross-functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results

Skills

Regulatory Affairs

IVD Regulations

Companion Diagnostics

Digital Pathology

Global Regulatory Strategy

IDEs

Performance Studies

Clinical Oncology

Cross-Functional Leadership

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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