Senior Director, Regulatory Affairs at Danaher Corporation

Brønshøj, Capital, Denmark

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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, HealthcareIndustries

Requirements

Demonstrated senior leadership experience managing direct reports and cross-functional teams across geographies, with a proven track record of coaching and developing high-performing talent
Ability to set strategic goals and drive execution, including prioritization of regulatory deliverables, acceleration of timelines, and measurable impact on compliance and time-to-market, including interactions with FDA, EU notified bodies, and other major health authorities
Proven success in leading global regulatory strategy and submissions for complex medical device or diagnostic products, including FDA, EU Notified Bodies, and international authorities, while translating regulatory intelligence into forward-looking strategies that support innovation, market access, and business growth
Demonstrated ability to lead or collaborate closely with Quality functions, ensuring effective QMS execution, regulatory compliance, RA process effectiveness, audits, inspections, and overall readiness across both Quality and Regulatory Affairs

Responsibilities

Develop and execute global regulatory strategies that align with business objectives, anticipate emerging requirements, and accelerate approvals across global markets
Lead and mentor a high-performing global Regulatory Affairs team, fostering accountability, collaboration, and building organizational capability through talent development
Serve as the strategic interface with global health authorities (including FDA, EU Notified Bodies, and other major agencies) to accelerate approvals, ensure compliance, and guide product development and commercialization
Position RA as a growth enabler, ensuring the business earns customer trust and exceeds stakeholder expectations by aligning regulatory strategies with business objectives. Partner with R&D, Product management, Clinical, and Commercial teams to guide product development from concept through commercialization and post-market surveillance
Drive regulatory innovation and process optimization by leveraging data, technology, and DBS principles to enhance regulatory effectiveness, strengthen global RA processes, ensure compliance, and foster a culture of quality and continuous improvement across QMS interfaces
Represent Radiometer externally to shape regulatory policy and advocacy in partnership with trade associations and regulatory bodies

Skills

Key technologies and capabilities for this role

Regulatory AffairsGlobal Regulatory StrategyComplianceMarket AccessTalent DevelopmentCross-Functional LeadershipStrategic PlanningTeam Leadership

Questions & Answers

Common questions about this position

What is the compensation for the Senior Director, Regulatory Affairs role?

This information is not specified in the job description.

Is this a remote position or does it require office presence?

This information is not specified in the job description.

What skills and experience are required for this role?

The role requires demonstrated senior leadership experience, along with the ability to develop global regulatory strategies, lead cross-functional teams, and interface with health authorities like FDA and EU Notified Bodies.

What is the company culture like at Radiometer?

Radiometer fosters a culture of belonging where unique viewpoints matter, celebrates diverse ideas and continuous improvement, and emphasizes harnessing Danaher’s system of continuous improvement to turn ideas into impact, with life coming first.

What makes a strong candidate for this Senior Director position?

A strong candidate will have demonstrated senior leadership experience in regulatory affairs, with expertise in leading global teams, developing regulatory strategies, and partnering cross-functionally to drive innovation and compliance.

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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