We are seeking a highly skilled Compliance Specialist to lead our international certifications and related processes for our healthcare products. The Compliance Specialist will play a crucial role in ensuring that our products meet all quality assurance and compliance requirements in the countries where we operate.
About the company: GRUPO DISBYTE is more than a startup; we're a powerhouse of creative minds and professionals, united by our shared love and passion for creating unique quality products and solutions from the ground up. Our purpose is straightforward yet very challenging, to democratize access to high quality products levering for this technological innovation.
Our origins trace back to the online marketplace where our entrepreneurial journey began. This foundation not only shaped our approach but also enabled us to incubate and launch a diverse range of products and services.
Today, these products stand as a testament to our commitment, sold exclusively within the marketplace. We take pride in our deep-rooted integration - from ideation to production. By collaborating closely with factories, we can present our offerings under our distinct brands, fostering a direct and authentic connection with our supporters making sure quality is always there.
As 2024 unfolds, we're on a quest to grow further, expanding our horizons, connecting with more people and continue making a meaningful impact.
If you resonate with our journey and our aspirations, then you just might be the person we're looking for. What would be your mission as the Compliance Specialist: Be the certification product owner for our healthcare products, taking ownership of certification and compliance throughout the useful life of the product, ensuring the business and its product are consistently compliant to regulatory requirements.
Key Challenges & Responsibilities for this Role Include: 1 - Plan and execute the certification process for our healthcare products (class I, II, and group C IVD) in all our markets, currently Colombia (INVIMA), Brazil (ANVISA/INMETRO), Mexico (COFEPRIS) and Argentina (ANMAT).
2 - Be the main contact for regulatory agencies and certification bodies.
3 - Be the main contact with suppliers and partners to create the certificatory folders (dossier) and guarantee all documents match the regulations needs.
4 - Communicate and train partners on new and existing performance standards and regulatory changes related to healthcare products.
5 - Develop compliance guidelines and training classes.
6 - Lead certificatory risk analysis throughout the development of new healthcare products identifying if project timing, cost and regulatory requirements could be met.
7 - Monitor product data throughout its lifecycle to ensure compliance with current and upcoming regulations.
8 - Collaborate with other departments to identify and mitigate product compliance risk in processes and products involved in launches and /or engineering changes.
9 - Proactively assess existing department processes for continuous improvement.
Key competencies: Bachelor´s degree in Engineering, Pharmacy, Biochemistry, or related.Strong knowledge of international regulations and standards and certifications related to healthcare products, such as ISO 13485 and IEC.Spanish and English fluency. Portuguese knowledge is an advantage.Proficiency in analysis of compliance procedures and regulatory standards. Organized individual with excellent analytical thinking skills.Persistent and structured with a goal-oriented approach to work.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.A minimum of 3 years of proven work experience as a compliance engineer or similar role for the healthcare industry in at least 1 of the 3 main certification bodies (COFEPRIS / ANMAT / ANVISA). Preferable more than one.
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