Regulatory Affairs Specialist III

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionCOMPANY: Thermo Fisher Scientific Inc.LOCATION: 168 Third Avenue, Waltham, MA 02451TITLE: Regulatory Affairs Specialist IIIHOURS: Monday to Friday, 8:00 am to 5:00 pmDUTIES: Provide Regulatory Affairs support to GSD project teams and external partners. 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 NGS software program. Create and maintain Device Master File (MAF). Participate in project activities and review key project documents such as product design protocols related to verification and validation, risk assessment. 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.Can work remotely or telecommute.REQUIREMENTS: MINIMUM Education Requirement: Bachelor’s degree in Regulatory Science, Biology, Chemistry, Bio-Engineering, or related field of study.MINIMUM Experience Requirement: 3 years of experience in any positions in which the required skills can be gained or a related occupation.Alternative Education and Experience Requirement: Master’s degree in Regulatory Science, Biology, Chemistry, Bio-Engineering, or related field of study plus 1 year of experience in any positions in which the required skills can be gained or a related occupation.Required knowledge or experience with: Regulatory Affairs or Quality Assurance experience in the IVD industry; Regulatory submissions; Design control, and cGMP/Quality Systems. Experience in the understanding of the balance and application of regulatory requirements; and Review of promotional marketing materials, advertising, and labeling.#LI-DNIThermo 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.