Regulatory Specialist
2 weeks ago
We are seeking an experienced Regulatory Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs with Clinical Trials. This role will be responsible for ensuring compliance with FDA regulations and other regulatory bodies and maintaining a high level of quality assurance throughout all aspects of the company.
Responsibilities:
- Oversee the development and implementation of regulatory strategies to ensure compliance with FDA regulations and industry standards.
- Coordinate and manage clinical trials, ensuring that all necessary documentation and submissions are completed in a timely and accurate manner.
- Collaborate with cross-functional teams to develop and implement quality control measures that align with FDA and IRB standards.
- Conduct research and analysis to stay current with changing regulatory requirements and ensure that the organization remains compliant.
- Develop and maintain policies and procedures related to compliance and regulatory affairs.
- Prepare and submit reports to regulatory agencies, including annual reports and product submissions.
- Provide training and guidance to colleagues on regulatory requirements and compliance procedures.
- Identify and mitigate risks related to regulatory compliance.
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this position. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
Skills required:
- Organizational skills (required)
- FDA regulations (preferred)
- Clinical Research (preferred)
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