- Title: Regulatory Affairs Associate
- Code: RCI-6504/6505
- Location: Irving Texas (TX) 75038
- Posted Date: 11/16/2020
- Duration: 12 Months
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
REGULATORY AFFAIRS ASSOCIATE - B
The position, under supervision of the manager, will help assist in preparing regulatory submissions to FDA and to international regulatory agencies for In-vitro Diagnostic products.
Position duties and responsibilities:
- Review and prepare the required documentation for submission following submission strategy and monitor applications under review.
- Help maintain regulatory documentation/technical files to ensure product information is current.
- Assist in maintaining current FDA and international regulations, guidance and applicable standards and communicate submission and approval requirements.
- Compile, review and coordinate submission documents for license renewals, product/manufacturing changes to Regulatory Agencies and Affiliates.
- Assist in maintaining various databases
- Participate in risk-benefit analysis for regulatory compliance.
- Assists with audits and inspections, as needed.
- Performs other related duties and responsibilities, on occasion, as assigned.
Must have the following:
- Candidate must be able to multitask and organize/prioritize tasks to meet deadlines in timely manner.
- Must have ability to work independently and in groups and demonstrate initiative, problem-solving and critical-thinking skills.
- Strong verbal and written communication with ability to effectively communicate with multiple functional areas in the organization is necessary.
- Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)
- At least one to three years of work experience.
- Understanding of scientific disciplines required.
- Understanding of FDA regulations governing submission processes, submission content, and specific time requirements for various submissions desired.
- Good computer skills required.