Manager International Regulatory Affairs Jobs Vacancy in Cepheid
Cepheid urgently required following position for Manager International Regulatory Affairs. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
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Manager International Regulatory Affairs Jobs Vacancy in Cepheid Jobs Details:
Manager, International Regulatory Affairs
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).
MANAGER, International Regulatory Affairs
Location: New Delhi, India
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 Greater India and S. E. Asia. The individual will provide regulatory compliance expertise for all processes and oversee internal site compliance to applicable regulations, standards, and quality systems through direct interactions across functional lines.
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. Interact with global regulatory leaders and peers to expedite approval of pending registrations
Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed. Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
Develop, track, trend and report to management on compliance metrics. Identify, communicate and escalate to Executive Management, as required, compliance issues and risks for further comprehensive action. Coordinate regulatory inspections ensuring oversight from Cepheid's global Quality group.
Provide guidance on import/export and distribution activities related to devices and reagents. Manage compliance with trade sanctions regulations.
Act as a liaison between the company and regulatory authorities, ensuring that products are imported and distributed in compliance with appropriate legislation.
Participate in the development and execution of quality/regulatory-related training and education.
Work interactively with cross-functional teams to achieve company business and compliance goals/objectives.
Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
Required Knowledge Skills and Abilities:
Bachelor's degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
A minimum of 10-12 years of experience in regulatory/Quality or related departments within an IVD or medical device industry
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
Able to travel 10-20% per the calendar year
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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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 : Asia Pacific-India-India
Schedule : Full-time