- Implement & maintain the effectiveness of the quality system
- Support manufacturing/operations day to day activities for change control
- Assist regulatory specialist in change control- and product development-related duties
- Provide regulatory assistance on team activities
- Interpret and apply regulatory understanding to support of products and teams
- Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide
- Handle regulatory activities involved in documentation, labeling, and field support
- Apply regulatory and technical knowledge to a wide variety of complex work assignments
- Maintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports
- Ensure compliance to and demonstrate knowledge of site- and division-level policies and procedures
- Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
- 2+ years' experience in Regulatory Affairs role.
- 1+ years' experience in an IVD or medical device manufacturing environment.
- Experience with quality systems and change control.
- Knowledge of US FDA regulatory registrations/submissions.
- Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio.
- On-site in Scarborough, ME
- 6-month contract from 6/3-EOY
- Pay Rate: Up to $40/hr ($80k annually)
- FT hours, M-F 8a-5p
- Business Unit: Infectious Disease
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Regulatory Affairs Specialist - Scarborough, United States - GForce Life Sciences
Description
Regulatory Affairs Specialist II – On-site in Scarborough, ME
RESPONSIBILITIES
QUALIFICATIONS
TERM & START