Senior Regulatory Affairs Specialist
| Verified Pay check_circle | Provided by the employer$69 - $74 per hour |
|---|---|
| Hours | Full-time |
| Location | Santa Clara, California |
Compare Pay
Verified Pay check_circleProvided by the employer$19.3
$25.11
$71.50
About this job
Job Description
Pay Range: $69.33hr - $74.33hr
Job Overview:
The Senior Regulatory Affairs Specialist will work with multiple business units to develop, update, and improve regulatory affairs processes. This role assists in implementing strategy and operations for regulatory activities, including directing product registration submissions, progress reports, supplements, amendments, and regulatory procedure updates to align with evolving global standards.
Duties:
- The candidate will work with multiple business units to develop, update, and improve regulatory affairs processes.
- Assist in implementing strategy and operations for regulatory affairs activities, including directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
- Update and develop regulatory affairs procedures to support changes in the regulatory landscape, including EU MDR.
- Identify opportunities for regulatory affairs process improvements and drive those changes to completion.
Skills:
- Working knowledge of EU MDR.
- Working knowledge of Regulatory Change Assessment.
- Working knowledge of US and EU medical device submissions.
- Experience supporting internal and external inspections.
- Ability to work cross-functionally and in a matrixed environment.
- Experience with continuous improvement activities.
Education:
- Bachelor's degree required.
Years Experience:
- Must have 3-5 years of experience in Medical Device Regulatory Affairs.
Benefits:
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.
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