Lead Quality Regulatory Specialist Position
About the Role:
We seek an experienced Lead Quality Regulatory Specialist to drive our client's Quality Assurance and Regulatory Affairs functions. This critical position will ensure their medical devices meet global regulatory requirements and quality standards.
Main Responsibilities:
* Develop and implement a strategic QA/RA plan, aligning with business objectives and regulatory needs.
* Oversee regulatory submissions and communicate with global regulatory bodies, including FDA, EMA, and Notified Bodies.
* Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other applicable regulations.
* Lead the implementation and maintenance of an ISO 13485 certified Quality Management System.
* Verify product development processes comply with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety).
* Manage internal and external audits, CAPAs, and risk management activities.
* Collaborate cross-functionally with R&D, Clinical, and Operations teams to ensure regulatory and quality requirements are met throughout the product lifecycle.
* Maintain awareness of global regulatory changes and updates internal processes accordingly.
* Foster a culture of compliance and continuous improvement by mentoring and developing the QA/RA team.
Requirements:
* Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
* Proven years of experience in QA/RA within the medical device industry.
* Experience with FDA submissions (510(k), PMA) and EU MDR compliance.
* Strong knowledge of IEC 62304, IEC 60601, and ISO 14971.
* Leadership experience in audits and managing QMS under ISO 13485.
* Excellent leadership, communication, and project management skills.
* Ability to work in a fast-paced environment.