When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

How will you make an impact?

The Regulatory Affairs Specialist is responsible for assisting in preparation, implementation, conformance and verification of Company quality policies and Regulatory Affairs procedures in compliance with 21 CFR Part 820 Quality System Regulations, 21 CFR parts 1300-1399, ISO 9000 series standards, all domestic and foreign import/export regulations, Thermo Fisher Scientific Regulatory Affairs Compliance programs, and applicable International standards.

What will you do?
 

• Develop, maintain and monitor programs for compliance with the Quality Systems Regulations and internal procedures.
• Assist the Quality Systems Manager in the preparation and control of regulatory documents.
• Prepare and control documents in support of product recalls and field actions.
• Prepare and submit all required Submissions to Foreign Governments.
• Input all information as necessary for new products including but not limited to formulation, processing and labeling data for product manufacturing.
• Review/approve documents including Device Requests, Label Copy, Device Master Records, Document Control Changes, Standard Operating Procedures Review promotional information and product literature to ensure regulatory compliance.
• Review governmental rulings to determine changes and probable effects on facility activities.
• Organize and maintain process for DEA chemical-controlled products, including overseeing all job functions that impact DEA chemical controlled products, advocate and train relevant personnel on DEA regulations including upcoming changes that impact the current process.
• Input all information as necessary for new products including but not limited to formulation, processing and labeling data for product manufacturing.
• Perform maintenance as necessary to existing product information.
• Participate as team member in Vendor, Customer, and Parent Company Audits. Participate in general review and update of Standard Operating Procedures according to Food & Drug Administration Quality System Regulations, ISO, and internal procedures.
• Perform duties in accordance with established company procedures and policies; perform other duties as assigned.
• Listen to and follow verbal and written instruction given in the English language.
• Report any actual or potential safety hazards to the Supervisor, Human Resources, Safety Specialist or Senior Management.

• Bachelor of Science degree, preferably in a biomedical field.

• Possess prudent and practical decision-making abilities, good written and verbal communication skills, and ability to work independently without direct supervision.
• Prefer knowledge of FDA, Medical Devices, and ISO regulations for device manufacturing.
• Knowledge of proper grammar/English/spelling and journalism skills to create and/or edit documents from oral, written or transcribed draft information.
• Basic math skills.
• Possess excellent verbal and written communication skills.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com