Regulatory Affairs/Regulatory Compliance Specialist

Scantibodies Laboratory Santee, CA
  • compensation depends on experience
    + Bonuses
  • Full Time
  • Health Insurance, Dental Insurance, Vision Insurance, 401K / Retirement
  • Employer Very Unlikely to Respond

Scantibodies is seeking a top Regulatory Affairs/Regulatory Compliance  Specialist to join our innovative team! If you have a minimum of four  (4) years of direct experience in the field and are familiar with a  variety of concepts, practices and procedures, as well as 501(k), GMP  and ISO experience, then we could be looking for you!

Essential Duties:
Ensure design control and product development are in control and compliance.
Evaluate, expedite and improve product development.
Increase quality adherence for all current products.
Conduct, evaluate and direct changes to ensure compliance
Handle all regulatory issues for the filing of 510(k), PMA, etc.
Submits regulatory submissions to the FDA to maintain licenses.
Represent regulatory and quality during FDA inspections.
Adhere to all GMP, ISO, and international regulatory requirements.
Keep abreast of regulatory developments within and/or outside of the  company as well as evolving best practices in compliance control.  This  includes plasma collection regulations.
Review and implementation of process improvement and systems to track trends/improvements by department heads.
Establish cost containment goals for the department and plans for implementation, review and tracking.
Implement and maintain the computer system Made-2-Manage as it relates to quality issues.
Evaluate vendors and conduct vendor audits as necessary.
Direct and coordinate investigations and resolution of all complaints related to vendor quality issues.
Direct and coordinate investigations and resolution of all customer complaints related to SLI quality issues.
Meet with customers and vendors as necessary.
Interact closely with customers on new product development.
Other related duties as assigned.

Equipment Used:
Personal Computer
General Office Equipment
Laboratory Equipment

Job Specifications:
Requires a minimum of 4 years of direct experience in the field.
Familiar with a variety of concepts, practices, and procedures.
Must have 510(k), GMP, and ISO experience.
Requires BS degree or equivalent.
Experience with FDA requirements
CAPA experience a must!
Understanding of medical terminology
Working knowledge of Outlook, Word, Excel and Visio
Occasional travel required

Working Conditions/Physical & Mental Demands:
Busy, fast paced, general office environment.

Benefits Include: Medical, Dental, 401K with company match, tuition  reimbursement and Incentive Compensation.  Must be able to pass a  background check, drug test and have a clean/valid Drivers license.     

Our Goal at Scantibodies is to see that each Patient receives the Most Accurate Result, using the Most Accurate Guide,so that they may receive the Most Accurate Treatment. Because at Scantibodies it is all about the Patient ...At Scantibodies, we believe that being your contract manufacturer is more than just an account. It is about trust and accountability. It is about taking your prototype to production for market readiness or making your current process more cost effective by using lean manufacturing concepts. Those are just a few of the many attributes that have made us a leader in contract manufacturing.

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