QA RA Specialist

Job Summary

Support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.

Key Accountabilities

• Support RAQA management with a business focus.
• Ensure compliance with RAQA record management processes.
• Lead and manage non-conformities, follow-up plans for CAPAs.
• Document tracking and control in SAP.
• Regulatory submissions to INVIMA and other regulatory entities.
• Preparation and updating of quality agreements.
• Internal customer document management.
• Management of regulatory and quality databases.
• Follow-up on regulatory processes with the factory.
• Follow-up and preparation of meeting and committee minutes.
• Provide technical and sanitary product documents.
• Issue letters to customers.
• Review registration requests received in detail and provide appropriate responses and support to stakeholders.

Managed Budget (if applicable) & KPI

• Ensure timely submission of regulatory dossiers.
• Track regulatory plans and quality assurance planning (audit plan, training plan, document management plan, change management, and risk management).
• Generate improvement proposals, continuous development, and involvement in projects.

Internal Networks/Key Relationships

To be determined based on departmental needs, including interactions such as:

• Customers
• External suppliers (logistics operator, certifying entities, INVIMA, ANDI, agen)
• Marketing managers
• Department managers/directors
• General Manager
• Commercial team
• Specialists and technical support team
• Clinical specialists

Skills and Abilities:

The ideal candidate for this position will exhibit the following core competencies:

• Analytical skills
• Numerical analysis
• Problem-solving
• Statistical knowledge
• Negotiation skills
• Leadership, empowerment
• Communication skills
• Systems management (MS Office, Internet, etc.)
• Creativity
• Excellent interpersonal skills
• Customer focus
• Integrity
• Innovation approach
• Good organizational skills
• Ability to work under pressure
• Teamwork
• Good interpersonal skills and a good listener
• Negotiation skills
• Proactivity
• Results-oriented

Minimum Knowledge and Experience Required for the Position:

• Education: Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
• Experience: Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
• Additional skills/knowledge:
  • Computer skills, including Word, Excel, and PowerPoint.
  • Language: Intermediate English.
  • Knowledge of ISO 13485 and/or ISO 9001-2015.

International Mobility:

• Required: 10%