Regulatory Affairs
hace 2 semanas
This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries regarding technical product information. You will be constantly interfacing with the global and regional quality and regulatory organization to ensure that we are delivering precise quality and regulatory information attending the customers´ expectations in what regards to timelines. The scope of the job is regional, supporting regional and global customers across product lines.
- Key Responsibilities:
- Product knowledge to complete customer and internal technical information (documentation) requests for the Latam region and support to the global team;
- Fulfill all documentation required by customers with a high-level quality and regulatory information respecting the customers timeline;
- Provide quality and regulatory support to customers in collaboration with other departments;
- Review formulas for compliance in our systems against customers´ requests and industry guidelines;
- Able to provide regional support to the Global Key Accounts;
- Deep understanding about the customers’ requirements;
- Primary contact to the customers;
- Keep documentation updated according to the regulations and guidelines;
- Support document automation by providing requirements and perform testing in the system;
- Ability to spot potential issues about the customers documentation;
- Provide support to our customers with expert advice and assistance in all documentation required;
- Provide documentation support to sales, IC&D, for product safety and regulatory issues;
- Understands the quality and regulatory framework to support customer's briefs;
- Support business maintenance;
- Contribute to the process improvement;
- Feed database to measure KPIs.
- Successfully manage the vast majority of all regulatory and quality needs (e.g. customer requests, regulatory changes and requirements etc.
**Job Requirements**:
**Required Skills**:
Bachelor’s degree required in science or related fields, or similar level through experience plus 10 years in quality assurance and regulatory affairs experience or Masters degree plus 7 years experience.
Excellent oral and written communication skills.
Able to communicate effectively with our internal and external stakeholders.
Accountability and ownership about the process.
Problem solving and decision making skills.
Perform responsibilities with a positive attitude and an ability to work with a mínimal level of guidance and supervision.
Strategic Thinking, works independently and proactively - with timely and accurate results.
Hands-on mentality, service oriented, with good organizational skills, and high attention to detail.
Shows a proactive & self-driven approach to learning and execution.
Ability to draw information from various sources and work with cross functional teams.
Demonstrate ability in collaboration skills, working within a team, and work under pressure.
Functional Technical Skills in relevant discipline
Able to operate effectively within our regulatory systems and office systems.
Required Experience:
Mandatory:
- Quality and/or Regulatory knowlodge across LATAM
- Experience on delivering documentation to customers.
- Spanish and English Fluent communication skills;
- Full understanding of common office software (Excel, Word, Outlook, etc.)
- Comfortable using IT platforms like CRM or SAP.
- Ability to work with systems.
Job Relevant Competencies:
- Ownership
- Accountability
- Be proactive
- Organization
- Commitment
- Communication - Good oral and written verbal fluency- Teamwork
- Ability to discuss problems and potential decisions in the necessary time
Job Location:
- Mexico
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