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Documentation Specialist
Job Location:
Job Location:
Fremont, CA - USA
Hourly Salary:
USD 30 - 33
Hourly Salary:
Posted:
25 October 2026 (11 hours ago)
Posted:
Application Deadline:
22 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
VARITE is looking for qualified Regulatory Affairs Specialist II in Fremont CA 94538 (Onsite)
WHAT THE CLIENT DOES
An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments clinical development solutions specialty diagnostics laboratory pharmaceutical and biotechnology services.
WHAT WE DO
Established in the Year 2000 VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850 global consultants VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific engineering technical and non-technical staff augmentation and talent acquisition services.
Job Title:Regulatory Affairs Specialist II
Location: Fremont CA 94538 (Onsite)
Contract Duration: 12 months with possible extension.
Pay Rate Range: $30.00 - $33.00/hr. on W2.
HERES WHAT YOULL DO
Position Summary
Key Responsibilities:
Tasks will include:
Minimum Requirements:
BENEFITS:
We offer a comprehensive benefits package designed to support the health well-being and financial security of our employees and their families. Eligible employees may receive:
If this opportunity interests you please respond by clicking on EasyApply.
Know someone who would be perfect for this role Refer to us and if they are hired you could be eligible for our employee referral bonus! Help us grow our team with top talent from your network.
VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion gender gender identity or expression sexual orientation national origin genetics disability age or veteran status.
WHAT THE CLIENT DOES
An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments clinical development solutions specialty diagnostics laboratory pharmaceutical and biotechnology services.
WHAT WE DO
Established in the Year 2000 VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850 global consultants VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific engineering technical and non-technical staff augmentation and talent acquisition services.
Job Title:Regulatory Affairs Specialist II
Location: Fremont CA 94538 (Onsite)
Contract Duration: 12 months with possible extension.
Pay Rate Range: $30.00 - $33.00/hr. on W2.
HERES WHAT YOULL DO
Position Summary
- The Regulatory Affairs Specialist II will draft assemble and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate of high quality and well supported by literature and regulatory foundations are presented in a manner to facilitate review and are in conformance with appropriate statutes regulations and guidelines
Key Responsibilities:
- The Regulatory Affairs Specialist II will join existing team and provide support for International Registration of IVD products.
Tasks will include:
- Initiation collection and coordination of information of regulatory documents for various purposes.
- Preparation and maintenance of product technical files for CE marking
- Organization and preparation of documents for international submissions including drafting reports and preparing documentation for submissions
- Coordination with international counterparts to obtain product approvals and renewals.
- Maintaining logs and trackers.
- Organize update and maintain regulatory documentation in accordance with department and company procedures.
Minimum Requirements:
- Bachelors degree in a scientific engineering or related field is required
- 2 years of experience working in regulatory environment RA/QA/R&D/QC
- Working knowledge and experience with IVD products
- Knowledgeable in the aspects of regulatory strategy creation design control cGMP/Quality Systems IVDR and import/export requirements
- Strong oral and written communication skills
BENEFITS:
We offer a comprehensive benefits package designed to support the health well-being and financial security of our employees and their families. Eligible employees may receive:
- Health Insurance: Medical dental and vision coverage
- Retirement Plans: Participation in a company-sponsored retirement savings plan.
- Legal Service Plans: Offering access to attorneys for legal advice and representation.
If this opportunity interests you please respond by clicking on EasyApply.
Know someone who would be perfect for this role Refer to us and if they are hired you could be eligible for our employee referral bonus! Help us grow our team with top talent from your network.
VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion gender gender identity or expression sexual orientation national origin genetics disability age or veteran status.
Required Experience:
IC
