Thermo Fisher Scientific Sr. Regulatory Analyst in Austin, Texas
Job Title: Regulatory Affairs Specialist III
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
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 will be located at the Austin TX site.
The Specialist will work in the Global Regulatory Affairs department supporting the novel sample preparation technologies used with PCR and capillary electrophoresis.
The position will require performing regulatory activities such as create / maintain Device Master File (MAF), draft and review 510ks, assist on-site audit and regulatory publishing activities, and review advertising and promotional materials on Class I and II IVD and RUO products.
In addition, the position may be required to provide regulatory assessment of the on market product changes, perform regulatory filing submission support by gathering documents in support of the submission, write assigned sections, or review the submission written prior to filing.
What will you do?
The Regulatory Affairs Specialist III will be responsible for providing Regulatory Affairs support to BID and GTS 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: the Director or 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.
Perform regulatory assessment of new and changed products
Provide regulatory support to existing and new cross-functional product core teams and serve as the regulatory core team lead for sample preparation device design 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) and EUA submissions as 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?
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
A minimum of 4 years within a technical environment; Regulatory Affairs, Quality Assurance, Software/System engineering, 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
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
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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