Principal, 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

Life Sciences, Diagnostics, Biotechnology, Medical DevicesIndustries

Requirements

Bachelor’s degree in science or engineering or equivalent experience
Extensive experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market. Experience supporting clinical trials a plus
In-depth working knowledge of FDA, Health Canada and EU regulatory requirements for IVD devices
Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including IVDR, 510k, PMA, and Health Canada submissions
Strong analytical mindset with a continuous drive for regulatory intelligence and minimal supervision needed
Ability to travel 15%, overnight, within territory or locations

Responsibilities

Serve as the Lead Regulatory Affairs representative on new product development teams for both IVD medical device and RUO products
Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and IVDR Technical File authoring
Provide regulatory guidance on product labelling, marketing materials, and product changes to ensure compliance
Collaborate cross-functionally with global teams and represent Regulatory Affairs on project teams, contributing regulatory intelligence and strategic input
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

Companion Diagnostics

Digital Pathology

Clinical Oncology

IDEs

Performance Study Applications

IVDR

510k

PMA

Global Regulatory Strategy

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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