Generis TEK Inc.
Generis TEK Inc.

Regulatory Specialist

South Portland, ME, US • Posted 20 hours ago • Updated 7 hours ago
Contract W2
12 Months
No Travel Required
On-site
Depends on Experience
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Job Details

Skills

  • (REGULATORY) AND (AFFAIRS) AND (IVD OR "IN VITRO DIAGNOSTICS" OR "INFECTIOUS DISEASE" OR BIOLOGICS OR DIAGNOSTICS OR "MEDICAL DEVICE" OR "REGULATORY SUBMISSIONS" OR "PRODUCT REGISTRATION" OR "REGULATORY DOCUMENTATION" OR "INTERNATIONAL REGISTRATION" OR "REGULATORY COMPLIANCE" OR "CHANGE CONTROL" OR QMS OR "QUALITY MANAGEMENT SYSTEM" OR LABELING)

Summary

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 # .
 

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91013946
  • Position Id: 9127993
  • Posted 20 hours ago

Company Info

About Generis TEK Inc.

Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing. We have 15 years of experience providing talented professionals to several Fortune 1000 clients. We are currently able to support clients across all locations within the United States with our unique client engagement models.

We at Generís Tek very highly value our relationship with our consultants. Our dedicated professionals help consultants reach their career objectives. We provide a competitive, fast-paced environment that promotes open communication to form a long term relationship built on mutual understanding, respect and trust. What sets us apart is the high level of service we provide to our clients after each employee is placed.

Our client relationships are backed by unparalleled understanding of workforce strategies, industry insight and expertise. As a trusted partner that has a strong recruiting focus, clients look at Generís Tek to meet their Talent acquisition needs. We have a solid database of qualified candidates that can be provided to our clients in quick turnaround time. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. Our business heavily relies on technology that gives a seamless solution to our clients and consultants. We offer our client intelligence about the talent market which helps them in their decision making and formulating workforce strategies at an optimum cost. We aspire to be our clients most trusted business partner.

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Salina Sawant

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