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 is a contract role that is expected to last at least 6 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: 8am to 4pm
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 trails comply with GCP

• Reviews 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 company is audit ready

Qualifications

• Need 8+ years of regulatory experience in a FDA regulated environment in the United States

• Expert in documentation and archiving

qualifications:

• Experience level: Experienced
• Minimum 8 years of experience
• Education: Bachelors (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.
  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 View email address on 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.