Seeking a new QA and Regulatory Manager to help support California operations. The responsibilities will be about 75% Quality Assurance and 25% Regulatory.

This is an onsite, full-time regular position. This person will need to be able to travel and work at both our Valencia and Burbank offices. The pay range for the position is $110K-$150k annually, depending on experience.

 
location: Valencia, California
job type: Permanent
salary: $110,000 - 150,000 per year
work hours: 8 to 4
education: Bachelors
 
responsibilities:

• Keeps the Director of Quality Operations informed of activities through reports, memos, and meetings; Serves as back-up to the Director of Quality Operations
• Manages and conducts relevant employee trainings
• Maintains additional quality systems and compliance as required.
• Responsible for the Customer Complaints and Returns program
• Conducts regulatory reviews and submits product registrations for NRC/CA-RHB SS&DRs, CMDR licenses, RMLs, FDA, MDD/MDR, import / export control, and others as applicable

 
qualifications:

• Bachelors or equivalent in a Scientific related field
• 5 years of relevant experience in medical devices or pharmaceuticals, preferably within Regulatory Affairs or a related field; 5 years of experience managing others. 5 years' experience in preparing submissions, including but not limited to product registrations and customer licensing for FDA, EU MDR, and other international markets.

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skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Submission Compliance, Quality Assurance (QA), Regulatory Audit Preparation, Regulatory Submission Writing, FDA Submissions, Medical Device Regulation (MDR), Issue Resolution Regulatory Specific, Internal Regulatory Audits, Global Regulatory Strategy Execution, Quality Management Systems (QMS)