Regulatory Compliance Specialist
5 days ago
Ventura Solutions LLC is looking for a highly skilled Regulatory Compliance Specialist to join our team in Union City, CA. As a Direct Placement employee, you will be responsible for ensuring compliance with quality and regulatory standards.
Estimated Salary: $120,000 - $180,000 per year
Job DescriptionThe successful candidate will have a strong background in regulatory compliance and medical device development, with experience in design control processes, risk management, and validation protocols. You will work closely with cross-functional teams to ensure product compliance with regulations and industry standards.
Your Key Responsibilities Will Include:
- Designing and executing validation protocols for manufacturing processes and product testing
- Collaborating with the Design and Development Team to ensure product development meets quality and regulatory standards
- Reviewing documentation, test results, and reports to ensure compliance with strict quality standards
- Providing technical support and facilitating the successful execution of Design Changes for mechanical surgical devices
Requirements
- Bachelor of Science degree in a technical discipline (Mechanical Engineering or Biomedical Engineering preferred)
- Prior experience with implants or instruments products required
- Minimum of 2-3 years of quality engineering or related experience in an FDA regulated medical device environment
- Proficiency with medical device development life cycles and Design Control processes
What We Offer
- Competitive salary range: $120,000 - $180,000 per year
- Opportunity to work with a reputable end-to-end medical device and combination product consulting firm
- Chance to develop your skills and expertise in regulatory compliance and medical device development
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