Sr. Regulatory Affairs Specialist
Company: Agilent Technologies, Inc.
Location: Santa Clara
Posted on: May 11, 2022
To protect the health and safety of our employees, contractors,
customers and communities, employees in the U.S. and Puerto Rico
are required to be fully vaccinated against COVID-19, unless an
approved exemption has been granted for a medical reason, sincerely
held religious belief, or an employee is otherwise exempt under
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 Global Regulatory Affairs Team is seeking a
Regulatory Affairs Specialist with a strong In Vitro Diagnostics
(IVD) background to support global Life Science and Applied Markets
Group product teams with new product introduction, registrations
and other regulatory deliverables. You will be part of a smart,
driven team that shares your passion for ensuring the highest
quality in the medical device field.As a regulatory affairs
specialist, you will help develop and implement programs to ensure
the company's products are safe, legal, and comply with national,
regional, and global regulations. The primary focus for this role
will be leading projects focused on helping LSAG product lines
comply with the In Vitro Diagnostic Regulation (IVDR) for products
to be marketed in the European Union (EU). You will also work
closely with other RA teams, Clinical Affairs, and other
stakeholders to provide regulatory guidance on projects and key
activities to assist the business in achieving its strategic
- Lead LSAG IVDR initiatives in multiple product lines.
- Provide guidance on creating and updating technical files.
- Compile required documents for any necessary regulatory
submissions, annual registrations, and license renewals.
- Prepare document packages for regulatory submissions for FDA,
EU (IVDR), and ROW.
- Participate on project teams to ensure compliance to national,
regional, or global regulatory requirements for EU, China, US and
other international markets as needed.
- Assist in the development of regulatory strategies for LSAG
- Manage improvement projects for the LSAG RA team and across
- Provide regulatory support & input to the business teams on
product development processes, such as design control (risk
management, design review, PLC consultancy), change management of
released products (DHF/DMR management, RA review for ECO/ECR).
- Assist with inspections, audits, and/or other agency
interactions with FDA or other regulatory bodies.
- Interact closely with enterprise QA/RA to identify relevant
standards and guidance documents that affect LSAG's business and
- Review and approve product and package labels as well as
marketing/promotional labeling material.
- Bachelors, Masters or University Degree or equivalent in
Engineering or Scientific/Technical discipline preferred; may
consider other education and/ or combination of education and
- Typically 8+ years relevant experience for entry to this
- Knowledge of medical device/IVD regulations as defined by FDA,
EU IVDR, ISO 13485, and other applicable standards experience with
writing and submitting regulatory submissions (FDA, EU, ROW).
- Strong written and verbal communication skills, especially
having the ability to explain and resolve differences in
interpretation of standards, regulations, and regulatory/compliance
- Effectively interact with, and understand, the different
stakeholders within a global, multi-business organization.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.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
+1-289-290-3856 or email firstname.lastname@example.org
Keywords: Agilent Technologies, Inc., Santa Clara , Sr. Regulatory Affairs Specialist, Other , Santa Clara, California
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