Manager, Regulatory Affairs
$99,000–$125,000 year
RemoteUnited States or Canada
Job Summary
Lead, coach, and develop Regulatory Affairs staff while managing the department budget, including salaries, vendors, and internal expenses. Oversee preparation and submission of U.S. and international regulatory filings, maintain all licenses and certifications, and serve as the primary contact during inspections and audits. Formulate regulatory strategies to support new product designations and coordinate with senior management and federal agencies on compliance issues. Travel up to 20% of time to MTF locations and suppliers as required. Monday through Friday 8:15am to 4:30pm. Salary Range: $99,000- $125,000/yr.
Required Qualifications
- Bachelor's degree in a scientific or related field, or a combination of education and equivalent work experience
- 7+ Years of overall experience
- 5 Years of Managerial experience
- 5 Years or Human tissue or medical device manufacturing
- Thorough understanding of FDA, QSR, cGMP, ISO regulations for medical devices, diagnostics or pharma
- Must exhibit people management, effective communication skills
- Attention to detail, critical thinking, problem-solving, and organizational skills
- Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma
- Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies
- Ability to travel up to 20% of time to MTF locations and to suppliers as required
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