Regulatory Affairs/Quality Specialist

Our client, a leading Medical Device manufacturer is looking for a Regulatory Affairs/Documentation person to join their growing company.

Responsibilities of essential functions include:
1. Appointed as Person Responsible for Regulatory Compliance (PRRC)
2. Leads the preparation, submission and maintenance of regulatory filing documents with the appropriate local, state and federal agencies
3. Prepare FDA submissions and CE Mark Technical Documentation File, including 510(k) submissions, Device Master Files, technical files and post market surveillance for product changes and/or new products as required to ensure timely clearance or approvals
4. Create and maintain regulatory submission timeliness and track deliverables to ensure company goals are met
5. Develop and communicate recommendations regarding new/emerging regulations to management and project teams
6. Represent the company and work directly with regulatory authorities on regulatory issues and submissions
7. Participate in cross-functional departmental meetings and discussions, provide input regarding regulatory strategy
8. Support to international customers regarding regulatory, import and/or export requirements and/or requests
9. Provide support in regulatory inspection or regulatory audits by any regulatory agency or customer audit
10. Adhere strictly to all CGMP, FDA, ISO, EU and company procedures to ensure the quality and integrity of the products and safety of the workplace
11. Responsible for document control
12. Responsible for the revision, distribution and maintenance of controlled documents including Standard Operating Procedures, Work Instructions, Forms, specifications and other miscellaneous documents
13. Responsible for maintaining controlled document libraries
14. Prepare controlled documents through the change control process including editing, proofreading, tracking, copying, distributing, scanning and filing
15. Maintain commitment to Quality Goals and Quality Policy
17. Working Schedule: 8:30 am to 5:15 pm