What are the responsibilities and job description for the Regulatory Manager position at Confidential?
Job Overview :
We are seeking a detail-oriented Regulatory Manager to ensure our company meets all regulatory and quality standards required by clients and government agencies. This role involves managing compliance documentation, assisting the sales team with regulatory requirements, and becoming the primary point of contact for regulatory conversations.
Key Responsibilities
Regulatory Compliance & Documentation
- Develop and maintain all quality and regulatory processes required by clients and government agencies
- Complete and maintain regulatory paperwork daily
- Organize and store all regulatory records and samples
- Stay up to date on client audits and regulatory requirements
- Cross-Departmental Support
- Assist the sales team in meeting regulatory requirements for clients.
- Become the key representative for all regulatory discussions with customers.
- Quality Management
- Oversee and ensure compliance wi th FDA, EPA, and TTB regulations.
- Implement and maintain quality management processes.
- Ensure all regulatory procedures are reviewed, implemented, and recorded.
Key Milestones & Goals :
Key Performance Indicators (KPIs) :
Qualifications & Experience :
Education : Bachelor's degree (Required)
Experience : Minimum 2 years in manufacturing (Required)
Experience : Class I / Class II / Class III Medical Devices
Benefits :