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Regulatory Affairs and Quality Assurance Specialist
hace 2 meses
Overview
Job Function: Regulatory Affairs & Quality Assurance
Position Summary
The successful candidate will play a pivotal role in supporting the execution and development of regulatory and quality strategies, ensuring compliance for products distributed by Werfen.
Key Responsibilities
- Assist RAQA leadership with a focus on business objectives.
- Maintain adherence to RAQA documentation management protocols.
- Oversee and resolve non-conformities, implementing corrective action plans.
- Manage documentation tracking and control within SAP.
- Prepare and submit regulatory documents to INVIMA and other relevant authorities.
- Draft and revise quality agreements as necessary.
- Handle internal customer documentation processes.
- Administer regulatory and quality databases effectively.
- Coordinate with manufacturing on regulatory matters.
- Prepare and document minutes for meetings and committees.
- Provide necessary technical and sanitary documentation for products.
- Communicate with customers through formal correspondence.
- Review and respond to registration requests from stakeholders in detail.
Performance Metrics
- Ensure timely submission of regulatory files.
- Monitor regulatory and quality assurance planning, including audit and training schedules.
- Propose enhancements and engage in continuous improvement initiatives.
Internal Collaborations
Interactions will be determined based on departmental requirements, including:
- Customers
- External partners (logistics providers, certifying agencies, INVIMA, ANDI, etc.)
- Marketing and department management
- Senior management
- Sales teams
- Technical support and clinical specialists
Required Skills and Competencies:
- Strong analytical and numerical skills
- Effective problem-solving abilities
- Knowledge of statistical methods
- Negotiation and leadership capabilities
- Excellent communication and interpersonal skills
- Proficiency in systems management (MS Office, Internet, etc.)
- Creative thinking and innovation
- Strong organizational skills and ability to work under pressure
- Team-oriented with a proactive approach
- Results-driven mindset
Qualifications:
- Education: Bachelor’s degree in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
- Experience: At least 2 years in Quality Assurance and Regulatory Affairs within the Medical Device and/or RDIV sector.
- Additional Skills: Proficient in Microsoft Word, Excel, and PowerPoint; Intermediate English proficiency; Familiarity with ISO standards.
Travel Requirements:
- Occasional travel may be required (up to 10%).
