Lead Functional Consultant - Quality Compliance Assurance
We are seeking a Lead Functional Consultant specializing in Quality Compliance Assurance to join our team.
You will work on IT quality management and compliance projects within the medical devices and pharmaceutical sectors. Apply now to contribute your expertise and advance your career.
Responsibilities
- Lead IT quality management, validation, and compliance initiatives within medical devices, pharmaceuticals, or biotech sectors
- Ensure adherence to FDA 21 CFR Part 820, Part 11, ISO 13485, EU MDR, and other regulatory frameworks
- Conduct Computer System Validation (CSV) and ensure GAMP 5 compliance
- Oversee regulatory submissions processes including 510(k) and PMA
- Perform IT audits, risk management, and CAPA processes
- Collaborate cross-functionally with IT, regulatory, R&D, and quality assurance teams
- Develop and maintain documentation and communication related to compliance and validation
- Provide guidance and training to team members on quality compliance standards
- Monitor changes in regulations and update compliance strategies accordingly
Requirements
- Experience of 7 to 14 years in IT quality management, validation, and compliance within medical devices, pharmaceuticals, or biotech
- Proven leadership experience in quality compliance assurance roles
- Proven project experience with Computer System Validation (CSV) and GAMP 5 compliance
- In-depth knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, EU MDR, and other relevant regulatory frameworks
- Strong understanding of regulatory submissions such as 510(k) and PMA
- Experience in conducting IT audits, risk management, and CAPA processes
- Excellent communication and documentation skills
- Bachelor's or Master's degree in IT, Computer Science, Biomedical Engineering, Regulatory Affairs, or related field
- English language proficiency at B2 (Upper-Intermediate) level or higher
