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Quality Assurance and Regulatory Compliance Specialist
hace 2 meses
Overview
Position Summary
The Quality and Regulatory Affairs (QA/RA) Trainee plays a crucial role in supporting the implementation of pre-market and post-market regulatory functions. This includes, but is not limited to, assisting in the preparation of necessary documentation and information required for product market presence, such as regulatory submissions, licensing, and registrations. The role also involves supporting post-market surveillance activities, including complaint evaluations, product corrections, removals, and recalls.
Key Responsibilities
- Aid in ensuring the company maintains proper registration and compliance with relevant national and international regulations.
- Collaborate in the preparation and submission of regulatory documents for market clearance, licensing, and registration.
- Support the execution of global corrective actions and product recalls.
- Assist in regulatory affairs interactions across various functional areas, providing essential support to the Tender and Sales departments to meet customer requirements, including but not limited to: Declarations of Conformity, EC Certificates, Instructions for Use, Labelling, Lot Certificates, and Safety Data Sheets.
- Ensure accurate upload and maintenance of documented information in the Company’s Information Systems related to assigned tasks.
- Uphold compliance with the Werfen Code of Ethics.
Networking and Key Relationships
This role may involve collaboration with the Tender Office, Sales and Marketing Office, Service Office, Supply Chain Office, and regulatory contacts of represented companies and manufacturers.
Required Knowledge and Experience
Education: Degree in a scientific, finance, or administrative discipline or equivalent experience.
- Experience: Not required.
- Additional Skills/Knowledge:
- Familiarity with local and international regulatory requirements.
- Proficient computer skills: MS Office, enterprise resource planning (ERP) systems, and other regulatory software tools.
- Language proficiency: Spanish and English.
Skills and Competencies
- Strong commitment to regulatory compliance and procedures.
- Excellent written and verbal communication abilities.
- Team-oriented with a collaborative mindset.
- Detail-oriented with a focus on delivering results.
- Customer-centric approach.
- Effective relationship management skills.
- Adaptability to a dynamic work environment.
