
Regulatory Compliance Specialist
5 days ago
The ideal candidate will play a pivotal role in overseeing quality assurance processes, ensuring seamless compliance with regulatory requirements for medical devices.
This professional will work closely with cross-functional teams to drive the successful commercialization of products, guaranteeing ongoing regulatory compliance.
Key responsibilities include:
- Product inspection and testing, ensuring adherence to industry standards.
- Hosting external audits and inspections, maintaining a high level of professionalism.
- Conducting internal and supplier audits, identifying areas for improvement.
- Ensuring timely product registrations as required per market.
- Managing the Quality Management System (QMS), promoting efficiency and effectiveness.
To be considered for this position, candidates should possess the following qualifications:
- University degree in life science, engineering, or other relevant field, providing a strong foundation for success.
- Comprehensive experience (+5 years) in both operational and strategic responsibility for QA and RA in the medical device industry.
- Expertise in registering products in different markets globally, leveraging knowledge to drive business growth.
- Knowledge of relevant regulations, including MDR, 21CFR Part 820, ISO 13485, ISO 14971, and ISO 11135.
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