Work Schedule

Environmental Conditions

Job Description

COMPANY: Thermo Fisher Scientific Inc.

LOCATION: 168 Third Avenue, Waltham, MA 02451

TITLE: Regulatory Affairs Specialist III

HOURS: Monday to Friday, 8:00 am to 5:00 pm

DUTIES: • 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.

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