Senior Director, US Regulatory Affair

Cepheid - Sunnyvale, CA (30+ days ago)3.7


Senior Director, US Regulatory Affair - CEP001865
About Us
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).

Description
Job Description
Job Summary

Senior Director, US Regulatory Affairs

The Sr. Director, Global Regulatory Affairs will manage personnel that prepare the regulatory submissions and interact with Core Team members, agencies/health authorities to obtain and maintain product approvals with a focus on US regulatory submissions. Interface with US FDA. Maintain regulatory intelligence and represent company for FDA and other regulatory groups.

Responsibilities:
Responsible for regulatory project timelines and management of global regulatory submissions.
Lead regulatory activities including planning and reviewing of regulatory submissions.
Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.
Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
Interact with global regulatory leaders and peers to expedite approval of pending registrations
Support RA functional area in the review and approval of Change Orders.
Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed.
Maintain a "focused urgency" as required by specific events
Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions
Assess potential impact and/or applicability to other related areas
Provide regulatory training to cross-functional groups

Qualifications

Required Education, Knowledge Skills and Abilities:
IVD product experience is required. Molecular diagnostics experience preferred.
Previous experience managing US 510k and submissions, PMA experience preferred.
Bachelor’s degree in a Life Science preferred. Or, equivalent combination of education and experience to perform at this level, PHd degree preferred.
Overall all 14+ years of experience in regulatory/Quality or related departments within an IVD or medical device industry
A minimum of 4-5 years management experience with at least 2-3 direct reports
Must be detail oriented with well-developed organizational and analytical skills
Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment
Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
Able to confidently deal with ambiguous issues and provide input towards suitable actions
Strong oral and written communication and presentation skills
Effective communicator of technical & non-technical information
Ability to work in a self-directed manner to see issues through to completion
Previous experience managing US 510k and submissions, PMA experience preferred.

Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Organization
: Cepheid
Job Function
: Quality and Regulatory Affairs
Primary Location
: North America-North America-United States-CA-Sunnyvale
Schedule
: Full-time