Regulatory Affairs Manager

4 days ago


Irvine, California, United States SysMind Tech Full time

Description of Job
SysMind Tech is looking for a qualified Regulatory Affairs Manager to oversee our regulatory compliance efforts. This role requires a high level of expertise in regulatory affairs, quality assurance, and compliance, with a focus on the Medical Device industry.

Responsibilities:
* Develop and maintain relationships with regulatory agencies, such as the FDA
* Ensure compliance with regulatory requirements, such as QSRs, MDD, and ISO 13485
* Collaborate with cross-functional teams to identify and mitigate risks
* Provide training and guidance on regulatory and compliance best practices
* Stay up-to-date with changing regulatory requirements and industry trends

Requirements:
* A minimum of 10 years of experience in regulatory affairs, quality assurance, and compliance
* Bachelor's degree in a relevant field (e.g., engineering, science, or healthcare)
* Excellent communication, organizational, and analytical skills
* Ability to work in a fast-paced environment and prioritize multiple tasks
* Strong knowledge of regulatory requirements, such as FDA, ISO 13485, and MDD

Salary:
$140,000 - $170,000 per annum

Location:
Irvine, CA, United States



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