Regulatory Manager- Medical Device
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POST DATE 8/26/2016
END DATE 12/2/2016
Santa Clara, CA
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.
The Life Sciences and Applied Markets Group (LSAG) is looking for a Medical Device Regulations Manager who will
- Develop and implement global regulatory strategy for medical device products in Agilent s Life Sciences and Applied Markets Group (LSAG), in close cooperation with Enterprise RA/QA, LSAG senior management and other related Agilent groups
- Build an efficient organization that supports pre-market, post-market and regulatory operations for LSAG medical device products
- Manage all aspects of the Medical Device Regulations (QSR, IVDD, ) for LSAG medical device products and own the resulting responsibilities in LSAG (incl. risk mgmt, design control, labelling control, change mgmt, complaint handling, recalls / field actions, MDR).
- Evaluate current processes & procedures and implement new and necessary improvements and additions
- Provide expert guidance and education to LSAG organization
- Monitor global regulatory changes and assure continuous compliance for LSAG medical device products and processes
- Manage facility inspections and audits from regulatory authorities and certification bodies in close cooperation with the Agilent Enterprise RA/QA function
- Bachelors, Masters or University Degree or equivalent in Engineering or Scientific discipline with 10+ years relevant business experience
- 5+ years of experience in IVD/medical device industry
- Profound knowledge of international medical device / IVD regulations such as FDA QSR, EU IVDD, MDD, and related standards such as ISO 13485, ISO 14971, IEC-61010-2-101
- Experience in establishing and managing a global regulatory strategy (including registrations, product listings / submissions) for medical device / IVD products
- Demonstrated strong management and leadership skills in implementing program/organization strategies
- Strong experience in integrating, guiding, and influencing global resources across several complex departments or functions
- Excellent communication and problem solving skills
- Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
- Has a sensitivity for working with other cultures
- Willingness to work globally within different time zones
- Technical Knowledge of Product Regulations including Safety, EMC, and Agilent Environmental Standards
- Experience with Agilent LSAG s products
- Experience working in mixed product environment: medical device, pharma, non-medical/clinical regulated
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:
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@example.com. EOE AA M/F/Vet/Disability..