Principal Specialist, Commercial Regulatory Affairs at Danaher Corporation

New Delhi, Delhi, India

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Diagnostics, Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree in science/pharmacy or related field with 10+ years of experience within the medical devices or IVD industry
OR Master’s degree in the field with 7+ years of experience
OR Doctoral degree in the field with 5+ years of experience

Responsibilities

Develop robust RA strategies and plans based on regulatory and business landscape
Ensure compliance with applicable local and regional regulatory requirements for India & SWA
Support business continuity and new growth opportunities through timely product registrations and renewals
Lead and manage timely submissions for new product registrations, renewals, post-approval changes, and lifecycle maintenance activities
Coordinate with manufacturers/legal manufacturers and cross-functional teams to ensure 100% on-time submissions in line with KPIs and metrics
Conduct impact assessments for regulatory changes and present findings to the Global Regulatory Council
Oversee post-market regulatory activities, including vigilance, reporting, and regulatory inspections
Review and approve promotional/marketing materials for compliance with applicable regulations
Represent the organization during audits and inspections related to regulatory processes
Monitor and communicate regulatory landscape changes, providing timely intelligence and actionable insights
Engage with regulatory authorities, trade associations, third-party organizations, and government bodies to influence policies and guidelines
Represent the company in external forums to shape regulatory frameworks
Partner with global, regional, and local teams to ensure regulatory alignment and knowledge sharing
Provide training and guidance on regulatory requirements and processes to local staff
Contribute to the development and improvement of local regulatory procedures, SOPs, and work instructions
Drive harmonization of best practices across regions

Skills

Regulatory Strategy

Regulatory Affairs

Product Registrations

Lifecycle Management

Post-Market Compliance

RA Plans

Compliance

Regulatory Authorities

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.

Land your dream remote job 3x faster with AI

Try Jobo Free