Address
Form of workJob Description
Regulatory Affairs/Quality Associate/design controls/engineering/regulations
34864 40-45.00 an hour w2 contract (neg) 5/27/2024 to 05/26/2025
Location: Alameda, California (ON-SITE role)
Emerging Regulations team- manages regulations and works with cross function teams. Regulations can be very narrow and specific. Analytical, proactive, communication skills, must do research and prep work to understand regulations before meetings with stakeholders. Some documentation work - identify gaps in processes or product design.
• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and assessment of emerging regulations.
• Recent experience with medical devices design controls; understanding of engineering change control process, familiarity with Agile PLM system
• May require an advanced degree and 2-4 years of direct experience in the field.
• Relies on analytical thinking and judgment to plan and accomplish goals.
• Performs a variety of tasks. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
• Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs.”
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: 5 pm to 1:30 am.
