Regulatory Compliance Professional
This is an exciting opportunity to work in the regulatory affairs department, ensuring compliance with global regulatory requirements and trends.
1. Collaborate closely with the Quality Assurance Manager to develop and implement effective quality management systems (QMS) that meet regulatory standards.
2. Oversee daily regulatory activities, manage multiple projects related to product enhancements and compliance, and ensure seamless interactions with auditors and notified bodies.
3. Work in conjunction with the QA Manager to address audit findings, implement corrective actions, and maintain a robust post-market surveillance system.
4. Support the team in preparing submissions for CE mark and FDA clearance, as well as other international regulatory filings.
5. Maintain awareness of emerging global regulatory trends and requirements, providing strategic insights to inform business decisions and ensure compliance.
6. Evaluate manufacturing and labeling changes for regulatory impact, coordinate investigations, and develop initiatives to improve products.
7. Stay up-to-date on domestic and international regulations, guidelines, and directives, advising key staff on compliance and non-compliance matters.
8. Prepare and submit 510(k) regulatory filings and engage in subsequent correspondence with the FDA.