Sr Regulatory Affairs Analyst
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At a glance
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Job overview
BOxES 4.0 Devices is hiring a Sr Regulatory Affairs Analyst. The Sr Regulatory Affairs Analyst ensures product compliance with regulatory requirements across the Northern Cluster in Latin America, collaborating with internal teams and external partners. The role prepares dossiers and documentation, maintains standards, develops regulatory strategies, implements processes in assigned countries, and communicates requirements regionally, requiring detail‑orientation and strong project management.
Key focus areas include Compile all necessary paperwork, evidence, and documentation required for regulatory submissions, Maintain compliance with relevant regulations, standards, and guidelines, and Work closely with cross‑functional teams to create regulatory strategies for new products.
Important skills include Regulatory Compliance, Software Project Management, Problem Solving, Leadership, Situational Leadership, and Communication. Preferred (not required): Regulatory Agencies Knowledge and Fast Learning.
Skills & qualifications
Skills
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Full job description
Sr Regulatory Affairs Analyst Toluca, Mexico
Research and Development Job ID: 33724 Apply Get Email Alerts • Responsible for ensuring that our products comply with all regulatory requirements in Northern Cluster, working closely with internal teams, and external partners to deliver new products to the market. This role requires a detail-oriented professional with a strong understanding of regulatory processes and the ability to manage multiple projects simultaneously.
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This position reports to the Manager, Registration and Regulatory Compliance Latin America Northern Cluster, and belongs to the GSARA (Global Safety Assessment and Regulatory Affairs) organization. KEY RESPONSIBILITIES
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Compile all necessary paperwork, evidence, and documentation required for regulatory submissions. This involves preparing dossiers, reports, and other relevant materials to regulatory authorities.
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Maintain compliance with relevant regulations, standards, and guidelines. This includes understanding and interpreting local laws related to product registration, labeling, and safety.
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Work closely with cross-functional teams, including legal, quality assurance, research and development, and marketing; on the creation of regulatory strategies for new products.
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Ensure that processes are understood and implemented in assigned countries of Northern cluster Latin America.
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Summarize and communicate regulatory requirements to the region/global.
REQUIRED EXPERIENCE YOU’LL BRING
- Bachelor´s degree in science, health or engineering.
- 2+ years work experience in regulatory/compliance-related field with progressively broadening responsibilities
- Proven situational leadership skills and demonstrated experience in influencing internal stakeholders as well as forging strong relationships with colleagues.
- Skills to work in an international context with different cultures.
- Commanding knowledge of compliance requirements in “home” country.
- Good communication skills, must be able to summarize and articulate technical information to diverse audiences both verbally and in writing
- Problem solving skills with the ability to bring project to final conclusion.
- A “can do” attitude and willingness to drive change that may not be inspired by him/her and is being asked of him/her
- Fluency in Spanish and English is essential
PREFERRED EXPERIENCES AND SKILLS .
- Proven Knowledge of Regulatory Agencies and Best Practices
- Fast learning skills
JOB REQUIREMENTS
- Full-Time (Tiempo Completo)
- Choose an item.
- Trabajo remoto de una vez por semana para empleados eligibles (4x1)
- Este puesto no es eligible para Relocalización
Inclusion & Diversity
We’re a global business, with people from every culture, ethnicity, race, religion, gender identity, sexual orientation, age and ability. We recognize the breadth of human experience, and we work to celebrate it. It is our goal to build a diverse, inclusive and supportive work environment where all people can thrive.
We’re committed to ongoing efforts that help us attract, hire, and retain diverse talent who want to build a positive, inclusive environment. Read more about our ongoing initiatives at https://jobs.scjohnson.com/inclusion (opens in new window) .
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