Regulatory Specialist
KYYBA
Scarborough, ME
Regulatory Specialist
KYYBA
Scarborough, ME
Expired: 14 days ago
Applications are no longer accepted.
- Contractor
Job Description
Company Info
Job DescriptionCompany Description
Experience:
- 2-5 years regulatory experience and/or 2 years 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
Education:
- BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
- Duties: 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.
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Kyyba is an Equal Opportunity Employer
Benefits:
Major Medical Coverage, including dental and vision
401k
Term life
Short-term disability
Long-term disability
Pre-paid legal plan
Identity theft plan
Medical and dependent FSA
HSA
Paid time off
Paid holidays
Opportunity for advancement
SELECT AWARDS
• An INC 5000 company for 10 years
• Corp! Michigan Economic Bright Spots
• Crain’s Detroit Business Top Staffing Service Companies in Detroit
• TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
• Best of MichBusiness winner in HR Wizards & Partnerships
• Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
• 101 Best & Brightest Companies to Work for in Michigan
Monday - Friday: 8:30am to 5pm.
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Kyyba is an Equal Opportunity Employer
Benefits:
Major Medical Coverage, including dental and vision
401k
Term life
Short-term disability
Long-term disability
Pre-paid legal plan
Identity theft plan
Medical and dependent FSA
HSA
Paid time off
Paid holidays
Opportunity for advancement
SELECT AWARDS
• An INC 5000 company for 10 years
• Corp! Michigan Economic Bright Spots
• Crain’s Detroit Business Top Staffing Service Companies in Detroit
• TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
• Best of MichBusiness winner in HR Wizards & Partnerships
• Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
• 101 Best & Brightest Companies to Work for in Michigan
Monday - Friday: 8:30am to 5pm.
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