What are the responsibilities and job description for the Regulatory Specialist position at Kelly Science, Engineering, Technology & Telecom?
Regulatory Affairs Specialist - Valencia, CA
Kelly® Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1 year) at a biotech company in Valencia, CA, with occasional work in Burbank. If you have expertise in regulatory submissions and quality operations in the medical device sector, and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Location: On-site in Valencia, CA and occasionally Burbank, CA
Pay rate: $38-$50/hour DOE
Schedule: Standard PST business hours Monday - Friday
Duration: Temporary (approx. 1 year)
Overview
The position involves assisting the Director of Quality Operations (DQO) in maintaining an effective Quality Operations and Regulatory Program. The role ensures high-quality products are consistently delivered on time by handling regulatory submissions, CAPAs, customer complaints, conducting regulatory reviews, and participating in audits. The Regulatory Specialist will also act as a back-up for Radioassay.
- Responsibilities:Assist the DQO in maintaining Quality Operations and Regulatory Program.
- Handle regulatory submissions, CAPAs, and customer complaints.
- Conduct regulatory reviews and participate in audits to ensure compliance with current procedures and applicable regulations.
- Keep the DQO fully informed on the status of QA, QC, DC, and RA activities.
- Serve as a back-up for Radioassay.
- Qualifications:Bachelor’s Degree in Science.
- 3-5 years of experience in biotech/medical device/pharmaceutical regulatory affairs
- Knowledge of FDA medical devices and/or pharmaceutical (drug) registrations.
- Familiarity with regulatory submissions and performing audits.
- Experience with QA systems: FDA, ISO 13485, MDR/MDD, MDSAP.
- Self-starter with strong communication skills and good time and project management.
- Detail-oriented, organized, with excellent verbal and written communication skills.
- Proficient in Microsoft Word, Excel, and ERP/MRP software.
- Must be onsite in the office 5 days a week.
- Must be available to work overtime if necessary.
Salary : $38 - $50
