Regulatory Affairs Specialist III
Regulatory Affairs Specialist III
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob 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 crossfunctional 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 exUS 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: Bachelors degree in Regulatory Science Biology Chemistry BioEngineering 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: Masters degree in Regulatory Science Biology Chemistry BioEngineering 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.
#LIDNI
Required Experience:
Unclear Seniority
Employment Type
Full-Time
