Are you ready to build something meaningful?- Take flight at Birdman!
The Company: At Birdman, we lead the charge toward a more sustainable future by revolutionizing food consumption through healthy, delicious, cruelty-free, plant-based products. Having achieved consistent 100% YoY 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 and be part of building the next Mexican Unicorn!
The Role: As the Regulatory Affairs Specialist your principal mission will be the evaluation of our products and processes to assure the regulatory compliance in national and international standards. You will be responsible of the recompilation of technical and regulatory documents for each product, label review, proceedings and visits of the various government agencies, and to stablish the required processes to assure the continuous improvement of the regulatory compliance. If you are passionate about regulations and standards, this is the place for you.
The Candidate: The ideal candidate will be capable of taking the regulatory compliance of our products to the next level. The ideal candidate has knowledge of national and international regulations, experience in proceedings before various government agencies and has special attention to detail to review the regulatory compliance of new products.
Responsibilities Develop and implement processes to assure the regulatory compliance of manufacture and products. Manage and integrate the regulatory and technical information to support the regulatory compliance of processes and products. Review and regulatory approve of new formulas and labels of the products according to the national and international regulations. Responsible of the proceedings and visits of the various government agencies (health). Maintain the certifications and leadership of the new certifications (regulatory). Review of technical documents (specifications, standards, etc.). Constat review of the updates of national and international regulations to assure regulatory compliance.
4+ years experience in dietary supplements, medical devices or pharmaceutical industry. 2+ years experience in regulatory affairs in dietary supplements, medical devices or pharmaceutical industry. Experience in proceedings and visits of various government agencies. Excellent writing abilities. Knowledge of Mexico regulations. Knowledge of FDA requirements. Knowledge of regulatory requirements for exporting. Experience in attending COFEPRIS audits.
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