Job summary
Job post source
This job is directly from Cepheid, a Danaher operating company, as indicated by the detailed company information and direct application instructions.
Job overview
The Regulatory Affairs Principal at Cepheid leads regulatory activities for new product development, ensuring compliance and approvals for diagnostic systems to impact global health.
Responsibilities and impact
The role involves preparing regulatory submissions, collaborating on new product core teams for timely launches, interacting with regulatory agencies, and implementing continuous improvements using Danaher Business System tools.
Compensation and benefits
The position offers an annual salary range of $143,400 to $197,100, eligibility for bonus/incentive pay, and comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k) plans.
Experience and skills
Candidates need a bachelor's degree with 8+ years, master's with 6+ years, or doctoral with 3+ years in relevant fields, experience leading regulatory affairs on medium to complex projects, and skills in regulatory submissions and strategy development.
Career development
Cepheid fosters career growth and development within a culture of continuous improvement and innovation, supported by the Danaher Business System.
Work environment and culture
The company culture emphasizes belonging, diversity, innovation, and continuous improvement, with a commitment to equal opportunity and accommodating individuals with disabilities.
Company information
Cepheid is a Danaher operating company specializing in molecular diagnostic systems and tests, focused on improving healthcare globally with innovative solutions.
Team overview
The candidate will join the Regulatory Affairs New Product Development department in Sunnyvale, CA, working on cross-functional new product teams under the Director of Regulatory Affairs, NPD.
Job location and travel
The position is based on-site in Sunnyvale, CA, with potential for some remote work and up to 25% domestic or international travel.
Unique job features
The role offers the opportunity to work on medium to complex diagnostic product projects, engage with US and EU regulatory agencies, and contribute to global health solutions through innovative regulatory strategies.
Company overview
Cepheid is a molecular diagnostics company specializing in the development, manufacturing, and commercialization of fully integrated systems for testing in clinical and non-clinical settings. They generate revenue through the sale of diagnostic tests and instruments, particularly their GeneXpert system, which offers rapid, accurate molecular testing for infectious diseases, genetic disorders, and cancer. Founded in 1996, Cepheid has been a pioneer in the field of molecular diagnostics, and their technology played a crucial role in the rapid testing for COVID-19 during the pandemic.
How to land this job
Tailor your resume to emphasize your experience leading regulatory affairs for new product development, especially with medium to complex assay, instrument, or software projects, aligning with Cepheid's focus on diagnostics and biotechnology.
Highlight your expertise in preparing and submitting regulatory documents such as 510(k), De Novo, PMA, IVDR, and WHO PQ, and your ability to navigate US and EU regulatory environments effectively.
Apply through multiple channels including Cepheid’s corporate careers page and LinkedIn to maximize your application visibility and follow up on your submissions.
Connect on LinkedIn with professionals in Cepheid’s Regulatory Affairs or New Product Development divisions; use ice breakers like commenting on recent regulatory changes impacting diagnostics or asking about their experience with Danaher Business System (DBS) continuous improvement tools.
Optimize your resume for ATS by incorporating key phrases from the job description such as 'regulatory submissions,' 'IVDR,' 'new product development,' 'regulatory strategy,' and 'Danaher Business System' to ensure your resume passes automated screening.
Leverage Jennie Johnson’s Power Apply feature to automate tailored applications across multiple platforms, identify relevant Cepheid contacts on LinkedIn for networking, and optimize your resume keywords, allowing you to focus more on interview preparation and career growth.
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