What are the responsibilities and job description for the Regulatory Associate position at MYCO USA?
- Job Description - Regulatory Compliance Specialist
Shift: 40 hours per week, Day Shift
Salary -$50,000 - $60,000
Position Summary
Seeking a Regulatory Affairs Specialist that can support our operations by making informed recommendations/suggestions on regulatory issues in order to move the registration process forward. The collaborative practice advises on all FDA-regulated product areas and will advise on issues throughout a product’s life cycle, including product development strategy, clinical trial compliance, pre-market submissions, labeling, advertising and promotion, adverse event reporting, warning letters, product recalls, agency inspections and remediation of inspection findings.
Essential Functions
- This role will work closely with the Regulatory colleagues of North America, Product Managers and R&D Chemists, and take on Regulatory responsibilities based on your skills and career aspirations.
- Review and communicate any health, safety, and environmental potential issues with company products.
- Research chemical compounds and Food Contact Notifications for R&D project development
- Support the Management in other regulatory tasks, including special projects
- Identify areas of improvement and increased efficiency
Requirements
Candidates should have FDA regulatory experience representing food, drug and/or device clients or commensurate experience working at the FDA. We will consider candidates who would be specialists or generalists within the regulatory and compliance practice.
Job Type: Full-time
Pay: $50,000.00 - $60,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Brookfield, WI: Reliably commute or planning to relocate before starting work (Required)
Experience:
- FDA regulations: 1 year (Preferred)
Work Location: In person
Salary : $50,000 - $60,000
