Regulatory Affairs Specialist
1 week ago
About the Role
AgNovos Healthcare is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for preparing regulatory submissions for our lead product to ensure compliance with regulatory requirements in the EU, US FDA, and other countries.
Key Responsibilities
- Coordinate and provide regulatory support for international regulatory submissions and FDA submissions.
- Maintain and update Technical Files and Design Dossiers to ensure compliance with current regulatory and company standards.
- Coordinate and prepare materials and presentations for internal meetings and FDA meetings.
- Maintain tracking tools for all regulatory submissions, communications, and documentation.
- Provide support to the Quality Assurance department for document control, audits, complaint handling, and CAPAs.
- Review regulations and guidance to stay up-to-date on regulatory changes and new developments.
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Regulatory Affairs Professional
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Derwood, Maryland, United States AgNovos Healthcare Full timeJob Opportunity at AgNovos HealthcareWe are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our team in Rockville, MD. The successful candidate will be responsible for preparing regulatory submissions, ensuring compliance with EU, US FDA, and other regulatory bodies.This role involves coordinating with internal teams and...
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Regulatory Affairs Specialist
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Derwood, United States AgNovos Healthcare Full timeCompany Description AgNovos is a biotechnology company that develops new treatments leveraging regenerative medicine to address persistent unmet medical needs related to bone disease. The Company was founded by Dr. James Howe, a renowned orthopedic surgeon who worked in clinical practice and research for more than thirty years. The first therapeutic area...
