Regulatory Specialist

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address can be reached on # .
We have Contract role Regulatory Specialist for client at South Portland, ME. Please let me know if you or any of your friends would be interested in this position.
Position Details:
Regulatory Specialist- South Portland, ME
Location                       : 65 Gannett Drive, South Portland, ME – 04106 (100% Onsite)
Project Duration      : 12 Months of contract
Shift Timings             : 8:00 AM to 4:30 PM (Monday to Friday)
Pay Range                   : $25.00-29.00 per hour on W2
Job 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. This job description will be reviewed periodically and is subject to change by management.
Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day to day activities for change control.
• Provides consultation/advice to regulatory specialist for change control and product development.
• Provides regulatory direction/interpretation on team activities.
• Interprets and applies regulatory understanding to support of products and teams.
• Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation, labeling, field support.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

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 MS Office, including Word, Excel, PowerPoint and Visio

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.

To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address can be reached on # .