Danaher Corporation Manager, International Regulatory Affairs in Sunnyvale, California
Danaher Company Description
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 atwww.cepheid.comor follow us on Twitter (@CepheidNews).
MANAGER, International Regulatory Affairs
The Manager, International Regulatory Affairs will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on Africa, S.E. Europe, Middle East and surrounding countries. Assist with ROW submissions as required.
• 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
• Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
• Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
• 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
• Assess corrective action to assure it prevents recurrence
• Provide regulatory training to cross-functional groups
Required Knowledge Skills and Abilities:
• Bachelor’s degree in a Life Science or related field preferred with 9 years experience. Or, equivalent combination of education and experience to perform at this level
• A minimum of 5-6 years of experience in regulatory/Quality or related departments within an IVD or medical device industry
• A minimum of 3-5 years management experience with atleast 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
• IVD product experience is highly 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.
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-CA-Sunnyvale
Req ID: CEP002850
Cepheid is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.