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Regulatory Affairs Specialist II

Location
South San Francisco, CA

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July 12, 2018
Location:
South San Francisco, California
Salary:
Competitive Salary
Type:
Full Time - Experienced
Categories:
Medical Device, Quality/Risk Management, Regulatory Compliance, Worldwide Regulatory Affairs
Preferred Education:
4 Year Degree
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
The Regulatory Affairs Specialist II will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines
Responsibilities:
Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests
Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues
Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews
Work with commercial partners in creating, retrieving, editing, and completing registration documentation for international regulatory applications
Applies advanced regulatory expertise to the evaluation and solution of submission problems
Actively reviews and edits documents associated with product development meetings
Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change
Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines
Responsible for vigilance activities, including filing and monitoring recalls/corrections/FSCA, incidents, and MDR’s
Review and interpret scientific literature and summarize effectively in writing
Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends
Ensure training and compliance with global quality system regulations
Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date
Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel
Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness
Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing
Contacts and Relations:
Regular contact and interaction with all levels of the organization
Daily interaction will occur with technical product owners
Accountability:
All Regulatory personnel are expected to maintain the confidentiality of sensitive laboratory information including testing data
Maintain a cooperative and professional relationship with other laboratory staff and departments
Minimum Qualifications:
Bachelor’s degree in Biology, Chemistry, Bio-Engineering or related scientific area
3-4 years of experience in the device/diagnostic, biologic, and/or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products
Well versed/knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
Experience in the balance and application of regulatory requirements
Direct and positive experience in communicating with Regulatory Authorities and Distributors
Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
Strong oral and written communication skills, as well as the ability to provide scientific presentations
Ability to compile data and summarize results
Hands-on, action-oriented, and able to implement effectively through his/her team
Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Able to work autonomously in a matrix-managed organization
Preferred Qualifications:
Background in diagnostics
IVD Regulatory Affairs experience
IEC 62304/Software Design knowledge
Post-market experience in an ISO 13485
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today ****Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
NOTES:
Additional Salary Information: Great benefit and 401 package available
Internal Number: 65535BR
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Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. As part of the team at Thermo Fisher Scientific, you will do important work like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your contribution will have real-world impact, and you will be supported in achieving your career goals.
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