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Job Details

Raqa senior analyst

  2026-01-27     Randstad     all cities,AK  
Description:

job summary:
A RAQA Senior Analyst for a medical devices and equipment manufacturing company is needed. Remote work. This role focuses on securing and maintaining product clearances from the FDA and Notified Bodies by managing complex regulatory submissions.

location: Remote, Remote
job type: Contract
salary: $60.71 - 68.64 per hour
work hours: 8am to 5pm
education: Bachelors

responsibilities:

  • Ensure regulatory compliance by performing thorough assessments for product clearances and approvals.

  • Prepare and manage submissions for the FDA, Notified Bodies, and other global regulatory agencies.

  • Serve as the primary regulatory resource and subject matter expert for cross-functional project teams.

  • Monitor and apply knowledge of current regulatory frameworks, legislation, and legal requirements.

  • Manage the planning, writing, coordination, and execution of complex regulatory items and filings.

  • Complete technical and scientific regulatory assignments that are broad in scope and complexity.

  • Work with minimal supervision, exercising independent judgment and ingenuity on routine tasks.

  • Maintain regular communication with senior leadership regarding project status and potential risks.

  • Handle specialized assignments requiring original solutions to meet compliance standards.

  • Coordinate with internal teams to ensure all documentation meets domestic and international standards.
Education and Experience:

  • Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related.

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
qualifications:
  • Experience level: Experienced
  • Education: Bachelors

skills:
  • Compliance
  • Quality

    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 ...@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.

    It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

    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.

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