Staff Regulatory Affairs Specialist

Job Summary Join a multi‑billion dollar manufacturing organization for a contract role as a Staff Regulatory Affairs Specialist. This role will be part of the regulatory team and will focus on preparing FDA regulatory submissions to support product clearances and approvals. An ideal candidate will have at least eight years of experience in an FDA‑regulated environment with U.S. experience. This contract role is expected to last at least six months (could be extended) and will work closely with cutting‑edge technology within the medical device industry. Location: Dublin, California Job Type: Contract Salary: $70-72 per hour Work Hours: 8 a.m. to 4 p.m. Education: Bachelors Responsibilities Lead the drafting and filing of critical FDA submissions Serve as primary point of contact for the FDA and governing bodies, managing all formal correspondence and responding to technical letters Partner with Clinical Affairs to manage approvals and ensure all clinical trials comply with GCP Review all product labels and marketing materials to ensure they align strictly with cleared claims and prevent illegal off‑label promotion Collaborate with international teams and mentor junior staff to develop launch strategies, maintain regulatory files, and ensure the company is audit ready Qualifications Minimum 8 years of regulatory experience in an FDA‑regulated environment in the United States Expertise in documentation and archiving Bachelor’s degree (required) Skills Regulatory Affairs / Compliance 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. #J-18808-Ljbffr Randstad USA