Seeking a Regulatory Affairs Specialist to support Quality Operations and Regulatory Affairs. This long-term temporary role is essential to maintaining regulatory compliance and supporting consistent, on-time product delivery. The successful candidate will be responsible for handling regulatory submissions, CAPAs, customer complaints, and supporting audits. This role also includes performing regulatory reviews and supporting other areas as needed.
Locations: Primarily based in Valencia with required travel to the Burbank site approximately once per week.
location: Valencia, California
job type: Contract
salary: $38 - 50 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
- Prepare and maintain regulatory submissions for medical devices.
- Support the Quality and Regulatory teams with CAPA investigations and customer complaint handling.
- Conduct internal audits and participate in external inspections/audits.
- Perform regulatory document reviews to ensure compliance with applicable standards and regulations.
- Assist with quality operations documentation and initiatives, keeping the DQO informed of QA, QC, DC, and RA activity status.
- Provide backup coverage for radioassay operations when needed.
- Other duties as assigned.
qualifications:
- Bachelor's degree (BS) in a scientific discipline or related field.
- Five (5+) years of experience in medical device regulatory affairs
- Familiarity with pharmaceutical regulatory requirements is desired but not required.
- Solid understanding of regulatory requirements and quality systems including FDA, ISO 13485, MDD/MDR, and MDSAP.
- Experience with regulatory submissions and internal / external audit processes.
- Proficient in Microsoft Word, Excel, and ERP / MRP systems.
- Must be highly organized, detail-oriented, and possess strong verbal and written communication skills.
- Ability to work independently, manage multiple projects, and meet deadlines.
- Willingness to work overtime as needed.
skills: Quality Assurance, Regulatory Affairs Operations, Submissions
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 in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
