Senior Quality And Regulatory Compliance Specialist

Senior Quality and Regulatory Compliance Specialist

The Opportunity:

The Senior Compliance Specialist is responsible for Quality Management System (QMS) document control, change control,
training curriculum, product complaints, facility registrations and licensing, product registrations and
licensing, product compliance, and product labeling compliance review.

What you'll do:
Manage the document control system to maintain the integrity of the QMS and ensure compliance
with applicable regulations, standards, and record storage and retention requirements.
Perform complaint handling and ensure compliance to applicable regulations and internal
procedures including mandatory reporting to regulatory agencies.
Manage training curriculum, assign training per management requirements, trend completion rates
Perform licensing and registration activities for the company and products (e.g. FDA medical
device establishment registration and product listing, state licensing,)
Review product labeling for compliance with applicable regulations and standards.
Complete periodic product compliance activities to maintain product compliance in applicable
markets (e.g. EU REACH, Prop 65)

What you'll need:

• 5-7 years of QA compliance experience in the medical device industry
• Experience working within ISO 13485 and/or ISO 9001 or other Quality Management
  System Certification
• Able to read and follow Standard Operating Procedures, Work Instructions, and Forms
• Detail oriented with good problem solving skills
• Excellent verbal, written, and interpersonal communication skills to work with all functional
  areas within the company