SAF Regulatory/Environmental Specialist II

Job Description Summary:

• Lead and track post-market surveillance activities for medical devices.
• Candidate will have a 4-year degree in science or engineering and be proficient in Microsoft Office applications.
• Attention to details and deadlines critical.
• Able to coordinate multiple deliverables and be forward-thinking
• Minimal work direction needed, highly skilled and knowledgeable to the position and provides best practicing sharing within work group.
• Non-employee to support EU MDR Post-Market Surveillance Activities Description: Attention to details and deadlines critical.
• Able to coordinate multiple deliverables and be forward-thinking

Additional Skills:

• Knowledge of ENOVIA as plus.
• One year of office experience OR master's degree is very helpful
• Enovia experience is strongly preferred (documentation control system) Other suites would be considered as well. Validation of documentation.

Role and Responsibilities: The Regulatory Affairs CW will be responsible for working with Source of Supply (SOS) Regulatory Affairs specialists tasked with fulfilling documentation required for global submissions. Specific responsibilities will include but are not limited to: * Utilization of the Market Registration System (MRS) to fulfill global requests for information. * Searching and retrieving documents in PLM and providing them for country requests. * Closely interact with SOS Regulatory Affairs Specialists, International Regulatory Specialists, and Regulatory Operations to ensure all deliverables are provided * Draft technical letters and completion of forms to fulfill country specific requirements * Tracking status of global registration requests and ensuring on time completion * Cross-functional collaboration with product teams to obtain information needed to meet specific documentation requirements

Qualifications and Education Requirements: University degree and at least 2 years of experience