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Regulatory Affairs Specialist

Organization
Agilent Technologies
Job Location
Remote
Santa Calara, CA 95051
United States
Benefits

Worldwide, many of our employees enjoy the following benefits:

 

  • Health and well-being programs that encourage wellness of the mind and body.
  • Financial benefits that include competitive salaries and bonuses, company stock, retirement programs, and insurance--and financial counseling to help make the most of it.
  • Programs that recognize the life and events our employees have away from work, and that provide opportunities to relax, recharge, and live a well-rounded life--all essential to the creative process.
  • Agilent’s Volunteer Time Off (VTO) program. We support giving back to the communities where we live and work, to communities in need around the world, and to our employees who give their time and talent through volunteer activities. A culture of continuous development that encourages our employees to stay up-to-date on current research and technology, and enhance their current skills to meet future needs.
  • The "extras" are the host of on-site conveniences, amenities, and services Agilent provides to help keep inspiration flowing. Offerings are designed to meet the unique interests and needs of the people who work at each site.

Find specifics for each country on our location pages.

Job Description

Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements. Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to customers and/or authorities requests/inquiries dealing with regulations and product compliance. Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level. May assess requirements and identify strategies for earliest possible approvals of clinical trials applications.

Roles and Responsibilities:

  • Serve as the regulatory representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required
  • New product development includes design, development and commercialization of assays for pathogen testing on RT-PCR, NGS and Microarray technologies
  • Assist in FDA EUA submissions, EU Self Certify / IVDR submissions and ROW submissions of products
  • Assist with the verification and validation experimental design; coordinate with regulatory affairs and R&D to confirm experimental design conforms to appropriate regulatory requirements
  • Create and update design and process FMEA
  • Review, create, and update traceability matrices
  • Conduct detailed reviews of all design history files; coordinate with project management, R&D, and manufacturing as needed ensure the project deliverables are complete, accurate, and in compliance with regulatory requirements
  • Coordinate efforts associated with the preparation of regulatory documents or submissions in a timely manner to facilitate worldwide product launches
  • Assess and update design and quality process documentation as required to elevate existing Research Use Only (RUO) products to Class I Clinical Laboratory Instruments, Software, General Purpose Reagents and/or CE-IVD regulations
  • Identify gaps and update Design History Folders (DHF) and Device Master Records (DMR) for the existing products
  • Identify gaps in design verification and validation and update them to meet the requirements of Class I and / or II / or EUA medical devices
  • Create and update technical files
  • Coordinate with production manufacturing to bring device master record documentation to QSR levels

 

Requirements
  • Bachelors or Master's Degree or equivalent in Biological science or equivalent
  • 4+ years experience within QA or biological manufacturing environment
  • IVD industry experience required 
  • Must have prior experience with wet-lab benchwork
  • Experience writing and executing validation protocols and reports for the medical device industry
  • Experience writing and submitting regulatory submissions (FDA, EU, or Canada) 
  • Experience in ISO13485 or quality environment supporting clinical markets
  • Proficient in Microsoft office suite

 Preferred Qualifications:

  • Genomics/Genetic Testing knowledge
  • Experience with bioinformatics and statistical design 
  • Experience using bioinformatics data analysis software
  • Prior experience with next-generation sequencing 

 

About Our Organization

Long History, Global Reach

 

Agilent's history can be traced to the 1960s when, as Hewlett-Packard, we entered the analytical chemistry market with our first gas chromatograph. Shortly thereafter, we expanded into mass spectrometry and liquid chromatography, and we've never looked back. With an HQ in the heart of the Silicon Valley and over 16,000 employees worldwide, we are now serving customers in over 110 countries.

 

 Pledge to our People

 

Agilent's success stems from our people, who make amazing things happen every day. As a truly global community, much of Agilent’s success is rooted in the diversity of our teams, customers, and partners as well as the commitment of those people to inclusion. Our diverse perspectives make Agilent a best place to work, recognized and awarded for our products, culture and values. Learn more about our awards and recognitions

 

 Purpose with an Impact

 

Agilent’s mission is to deliver trusted answers and insights that enable our customers to advance quality of life. Our innovations, solutions and expertise enhance outcomes in the efforts to improve the quality of our air, food, water and soil, conduct ground-breaking Nobel Prize research, and increase the precision of cancer diagnoses and targeted treatments for patients.

 

 Our Values and Culture

 

Our OneAgilent culture is built on the values we live every day. Innovation and contribution - Uncompromising integrity - Trust, respect, and teamwork – Speed – Focus - Accountability. We focus intensely on our customers, acting as owners, innovating and simplifying with urgency. We welcome feedback, recognize our successes and continuously develop.

 

 Development opportunities

 

Agilent’s culture of innovation encourages employees to stay at the top of their game. Our structured development programs provide the fuel to enable this continued learning and growth, while our global reach and internal mobility open the door to new possibilities.

 

 Living a well-rounded life

 

Our employees have both time and opportunities to enjoy life, their family, and friendships while engaging in a rewarding career. It is the essence of how we work. Our flexible approach (role and location permitting) to time off, schedules, work location, activities, help employees keep things in perspective while keeping inspiration flowing.

 

 Commitment to Sustainability

 

We are committed to sustainability in our products, our operational practices and the support of our employee teams. We believe that it is our responsibility to help build a safer, more sustainable world. All of our actions are based on our long-standing values, and achieved with uncompromising integrity. Learn more.

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