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Manager, Regulatory Affairs

Company: Thermo Fisher Scientific
Location: Austin
Posted on: November 19, 2021

Job Description:

*How will you make an impact?*

* Thermo Fisher is seeking a Regulatory Affairs professional to join the exciting area of molecular diagnostics and sample collection and preparation! Main area of focus includes creating regulatory strategy for the sample prep and collection business unit as they drive innovative/forward thinking solutions to connect and automate the molecular workflow.
* This position will provide strategic and tactical support to the sample collection and preparation core teams.
* The position will work in the Regulatory Affairs department and will establish and execute global regulatory strategies, lead FDA pre-submission package development and subsequent meetings and author final product submissions (510(k)s, IVDR, etc.) and other global product submissions.
* This Regulatory Affairs professional will support the Bio-Sciences Sample Prep and Collection business unit.
* This position will lead a team and provide strategy mentorship and support.
* What will you do?*
* Responsible for providing guidance to assure that all regulatory submissions are planned, communicated and carried out per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
* People leader providing support and guidance across divisions
* The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals.
* Implement regulatory strategies for product submissions.
* Facilitate and prepare U.S. regulatory Pre Submission or submission documents
* Lead FDA pre submission and submission meetings
* Support and guide team members through submission.
* Support global regulatory registration representatives for product global registration activities
* Perform regulatory assessment of new and changed products.
* Pay attention to new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
* Conduct trainings and/or communicate materials, as needed, in order to enhance team's knowledge of working in a regulated environment.
* Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
* How will you get here?*
* Education*
* A B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
* Experience:*
* Must have a minimum of 5-7 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics or Medical Devices
* This experience must include either BLA, 510(k), PMA, CE IVD submissions or equivalent. Must be well versed 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 regulatory guidance and RA strategies.
* Experienced people leader
* Experience in the balance and application of regulatory requirements
* Direct and positive experience in communicating with Regulatory Authorities and co-development partners.
* Regulatory review of promotional marketing materials, press releases, labeling, etc.
* Demonstrate understanding of 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
* Knowledge, Skills, Abilities*
* High energy level; positive attitude; works well under stress, Strong communicator and leader
* Hands-on, willing to take action, 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 complex organizational structure
* Ability to provide solutions based on knowledge of regulation and industry experience
* Willingness to travel (-10-15%)
* Comfortable with ambiguity and change

Keywords: Thermo Fisher Scientific, Austin , Manager, Regulatory Affairs, Executive , Austin, Texas

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