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Regulatory Affairs Specialist III - IVD Genetic Sequencing

Location
Carlsbad, CA

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Job Description
Job Title:
Regulatory Affairs Specialist III
Requisition ID:
67236BR
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.
Location/Division Specific Information
South San Francisco, Carlsbad or Pleasanton, CA
How will you make an impact?
Thermo Fisher is seeking a Regulatory Affairs Specialist III to join the exciting area of in vitro diagnostics.
This position will provide tactical support to In-Vitro Diagnostic core teams and can be located at either the Carlsbad, CA, Pleasanton, CA or South San Francisco, CA sites.
The Specialist will work in the Global Regulatory Affairs department supporting the novel technologies such as capillary electrophoresis, PCR, Next Generation Sequencing.
The position will require performing regulatory activities including providing regulatory assessment of the on market product changes, performing regulatory filing submission support by gathering documents in support of the submission, writing assigned sections, or reviewing the submission written prior to filing.
In addition, the position may require performing regulatory activities such as review advertising and promotional materials on IVD and RUO products, assist on-site audit, and create / maintain Device Master File (MAF).
What will you do?
The Regulatory Affairs Specialist III will be responsible for providing Regulatory Affairs support to GSD and CSD project teams and external partners.
The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department and will have direct line reporting to: Sr. Manager of Regulatory Affairs.
Prepare, collect or coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners
Review product labeling, advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
Create and maintain Device Master File (MAF)
Perform regulatory assessment of new and changed products
Provide regulatory support to existing and new cross-functional product core teams
Participate project activities and review key project documents such as product design protocols related to verification and validation, risk assessment, etc.
Provide support in 510(k), PMA or PMA supplement submissions if needed.
Facilitate preparation of ex-US registrations and communicate with Regulatory Affairs counterparts in other regions (outside the US) to ensure registration documents are provided in a timely fashion to support existing IVD products.
Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
How will you get here?
Education
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
Experience:
A minimum of 3 years within a technical environment; Regulatory Affairs, Quality Assurance, or R&D experience preferred.
Must have familiarity in the aspects of regulatory submissions, design control, and cGMP/Quality Systems.
Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Capacity to communicate regulations to technical functions within the company
Location: Role can be based in Frederick, MD, Carlsbad, CA, Pleasanton, CA, or South San Francisco, CA
Required Qualifications:
High energy level; positive attitude; works well under stress, Strong communicator and leader
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
Willingness to travel (10-15%)
Comfortable with ambiguity and change
At Thermo Fisher Scientific, each one of our 65,000 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.
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.

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