qa & regulatory manager.

job summary:
Client is adding to their team, they're seeking a new QA and Regulatory Manager to help them with their 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 equivelent 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.

#LI-CV1

 
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)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.