Regulatory Specialist II

Job Description

Exempt/Non Exempt: Non Exempt Years 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. 

Disclaimer: 

Kyyba is an Equal Opportunity Employer.

Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans /Veteran Spouses/ Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”

 

Rewards:

Medical, dental, vision

401k 

Term life

Voluntary life and disability insurance

Optional Pre-paid legal plan

Optional Identity theft plan

Optional Medical and dependent FSA

Work-visa sponsorship

Opportunity for advancement

Long-term assignment with opportunity for hire by client 

 

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