Regulatory Affairs Principal at Danaher Corporation

Sunnyvale, California, 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, Biotechnology, Medical DevicesIndustries

Requirements

Bachelor’s degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 8+ years of related work experience OR Master’s degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience
Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects
Complies, prepares, reviews, and submits regulatory submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ)
Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations
Actively participates in project core teams, developing regulatory strategy and plans and collaboratively achieving project goals and meeting timelines
Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status
Potential travel either domestic or international up to 25%

Responsibilities

Prepare regulatory submissions and interact cross-functionally on new product core teams to ensure On Time Delivery (OTD) of product launches
Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required
Serves as representative to gather and interpret new and changed regulations and guidelines in the US and EU
Implements continuous improvements and efficiencies using DBS tools
Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions
Ensuring design controls are met

Skills

Key technologies and capabilities for this role

Regulatory AffairsIVDRUS FDAWHO PQRegulatory SubmissionsNew Product DevelopmentDanaher Business SystemCross-functional Collaboration

Questions & Answers

Common questions about this position

What are the education and experience requirements for this role?

A Bachelor’s degree in applicable fields like biological sciences, biomedical engineering, or chemistry with 8+ years of related work experience is required, or a Master’s degree with 6+ years, or a Doctoral degree with 3+ years.

Is remote work an option for this position?

The position is located in Sunnyvale, CA, but remote work may be considered in certain situations.

What does the role involve in terms of regulatory responsibilities?

The role requires serving as RA lead on New Product Development core teams for medium to complicated assay, instrument, software projects, preparing regulatory submissions like 510(k), PMA, IVDR, interacting with agencies, and developing regulatory strategies.

What is the company culture like at Cepheid?

Cepheid fosters a culture of belonging where unique viewpoints matter, emphasizes continuous improvement through the Danaher Business System, and supports career growth and development in an environment passionate about improving healthcare.

What makes a strong candidate for this Regulatory Affairs Principal role?

Strong candidates have advanced degrees in relevant fields with substantial regulatory experience, expertise in leading NPD teams on complex projects, and skills in preparing submissions like 510(k), PMA, and IVDR while participating in cross-functional teams.

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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