Duration: 12 Months--Possible extension
Description:
The position of Regulatory Affairs Specialist I is within our Infectious Disease business unit located at Scarborough, Maine. In this role you will with general guidance, perform a variety of functions in support of domestic and international product registrations for new and modified products.
Responsibilities: - Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Assists in the research of scientific and regulatory information in order to write submission documents.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Ensures compliant shipment of products through the maintenance of applicable inclusions, spreadsheets, etc.
- Adds and maintains information contained in the Global Regulatory Information Database.
- Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.
- Organizes and maintains hard copy and electronic department files.
- Keeps informed of global regulatory information.
- Assists in developing internal procedures and tools.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Client’s Quality Management Systems per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Basic Qualifications:Education:- Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
Competencies:- Knowledge of Federal Regulations
- Demonstrated written and verbal communication skills
- Strong time management skills, with the ability to work on multiple projects simultaneously
- Ability to work independently as well as within a team
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio, Client’s Quality Management System per ISO, FDA, and other regulatory agencies.
Years Experience:- 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
Skills:- Knowledge of regulations and standards affecting IVDs and/or biologics.
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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