Regulatory Affairs Specialist- Companion Diagnostics

Organization
Agilent Technologies, Inc. US
Job Location
Santa Clara, CA
Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
We are looking for a highly motivated and experienced Regulatory Affairs professional to join Agilent DGG Companion Diagnostic Regulatory Affairs group. The role will work as individual contributor reporting to senior RA manager. 
Responsibilities
• Provide regulatory assessment and plans for US and international product registrations and approvals
• Provide expertise in regulatory affairs leading to successful registrations and approvals of companion diagnostics in global markets
• Work across the organization to ensure alignment of regulatory processes and compliance 
• Ensure the accurate and timely preparations of regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contract.
• Under supervision, interact and collaborate with pharma partners in joint meetings



Requirements: 

• University degree (Bachelor or Master's) in related field (biological science, advanced degree or regulatory affairs certification preferred) or equivalent combination of education and experience.
• 4+ years of RA experience in IVD or medical device field. 
• Strong history of successful regulatory submissions, registration (PMA, 510k)
• Excellent communication skills 
•Experience working in projects as part of project teams 
•Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements. 
•Knowledge of pathology and/or oncology is preferred.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster available here:
https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf,
https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Suppleme...
Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-754-5030 (US and Canada only) or email [email protected]. EOE AA M/F/Vet/Disability

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