Regulatory Compliance Specialist
hace 3 semanas
At Birdman, we're revolutionizing food consumption by introducing healthy, delicious, cruelty-free, plant-based products. Our commitment to sustainability has led to consistent 100% year-over-year growth for eight consecutive years.
We're poised to expand into new markets and introduce innovative business lines, reaching new heights while maximizing positive impact. Join us in shaping the next era of sustainable food practices.
The Role: Regulatory Affairs SpecialistThis is an exceptional opportunity for a highly motivated and detail-oriented individual to lead our regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring our products and processes comply with national and international standards.
Your primary mission will be to evaluate our products and processes, recompiling technical and regulatory documents, reviewing labels, conducting proceedings and visits with government agencies, and establishing processes to maintain regulatory compliance.
You will play a crucial role in maintaining certifications and leadership in regulatory areas, reviewing technical documents, and staying up-to-date on updates to national and international regulations.
Responsibilities- Develop and implement processes to ensure regulatory compliance of manufactured and sold products.
- Manage and integrate regulatory and technical information to support regulatory compliance.
- Review and approve new formulas and labels according to national and international regulations.
- Lead proceedings and visits with various government agencies (health).
- Maintain certifications and leadership in regulatory areas.
- Review technical documents (specifications, standards, etc.).
To succeed in this role, you'll need:
- 4+ years' experience in the dietary supplements, medical devices, or pharmaceutical industry.
- 2+ years' experience in regulatory affairs in the same industries.
- Experience in proceedings and visits with various government agencies.
- Excellent writing abilities.
- In-depth knowledge of Mexico's regulations.
- Familiarity with FDA requirements.
- Understanding of regulatory requirements for exporting.
- Experience attending COFEPRIS audits.
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