What are the responsibilities and job description for the Regulatory Manager position at Course?
Job Overview:
We are seeking a detail-oriented regulatory professional 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 with FDA, EPA, and TTB regulations.
- Implement and maintain quality management processes.
- Ensure all regulatory procedures are reviewed, implemented, and recorded.
Key Milestones & Goals:
- Achieve full FDA compliance.
- Ensure EPA compliance with proper procedures in place.
- Establish TTB reporting procedures and ensure compliance.
- Take full ownership of Quality Management within the organization.
Key Performance Indicators (KPIs):
- Weekly review and confirmation of regulatory paperwork completion.
- Ongoing education on industry regulations and compliance.
- Proactive management of client audits and regulatory updates.
Qualifications & Experience:
Education: Bachelor's degree (Required)
Experience: Minimum 2 years in manufacturing (Required)
Experience: Class I/Class II/Class III Medical Devices
Benefits:
- 401(k) matching
- Life insurance
- Monday to Friday schedule
