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Regulatory Affairs Specialist
Hercules, CA
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Take your regulatory affairs experience to the next level with an exciting opportunity supporting innovative in vitro diagnostic (IVD) products. This role offers hands-on involvement with global regulatory submissions, cross-functional collaboration, and the chance to make a meaningful impact in the clinical diagnostics industry while working with a leading life sciences organization.
Location:
Hercules, CA (Onsite)
Pay Rate:
$40/hour
Employment Type:
Contract through 12/31/2026
Schedule:
Day Shift
Why This Role Matters
In this role, you will help support global regulatory activities for IVD products used in clinical diagnostics. Your work will contribute to worldwide product registrations and regulatory compliance efforts, helping bring important diagnostic solutions to healthcare providers and patients.
What You'll Do
Assemble low- to medium-complexity regulatory submissions supporting worldwide product registration change requests for IVDR
Provide regulatory support across multiple IVD product groups within clinical diagnostics
Collaborate closely with Regulatory Affairs, R D, Quality Assurance, Planning, and Manufacturing teams
Interface daily with desktop publishers, technical writers, and regulatory specialists
Review and organize scientific and regulatory documentation to support submissions
Utilize electronic systems and databases to manage regulatory data and records
Apply analytical and problem-solving skills to support daily regulatory activities and project deadlines
What We're Looking For
A current, up-to-date resume
Bachelor's degree in Biology or another scientific field
6 months to 2 years of experience in IVD Regulatory Affairs
Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and Teams
Strong prioritization skills with the ability to manage multiple projects simultaneously
Excellent communication skills and ability to work effectively across departments
Highly organized with strong attention to detail and time management skills
Technical aptitude and ability to understand IVD product features and functionality
Understanding of databases and electronic document management systems
Laboratory research experience in an IVD medical device regulated environment strongly preferred
Understanding of scientific reports, risk management processes, and Quality Systems
Ability to meet compliance requirements
What's In It For You
Competitive pay at $40/hour
Gain valuable experience supporting global IVDR regulatory submissions
Opportunity to work cross-functionally with industry professionals and subject matter experts
Expand your knowledge of clinical diagnostics and regulated medical device environments
Build experience with regulatory documentation, systems, and processes in a global organization
Develop professional skills in project management, collaboration, and regulatory compliance
Benefits for Manpower Associates (Upon Eligibility)
Upon completion of waiting period associates are eligible for:
Medical and Prescription Drug Plans
Dental Plan
Supplemental Life Insurance
Short Term Disability Insurance
401(k)ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment.
It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.