Post Market Regulatory Affairs Specialist

Qualifications

EXPERIENCE: -

• Ability to work in a cross-functional matrix environment - Active listening/phone skills - Collaboration and teaming skills - Critical thinking skills - Detail orientation - Organization skills - Prioritization and multi-tasking skills -
• Strong verbal and written communication skills -
• Knowledge of basic medical terminology -
• Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, Sharepoint) - Continuous learner - Global mindset - Accountability for own work - Problem solving/root cause analysis skills Job Description: Responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Regulatory Specialist is responsible for oversight and direct support of technical evaluations and investigation tasks required for complaint processing/closure. The Customer quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: - Responsible and accountable for on-time submission and accuracy of regulatory reports -
• Review and complete determination associated Medical Device
• Report and/or Vigilance
• Report -
• Knowledge of and familiarity with global regulations for reporting - Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events. -
• Interact positively with internal, external business partners and colleagues - Adhere and comply to work instructions, standard operating procedures, and regulations. - Expedite investigations by collaborating with internal/external business partners - Achieve productivity targets - Achieve accuracy targets for complaint documentations -
• Participate in projects and events - Complaint determination - Reportability assessments - Conduct follow-ups with complainant, reporters - Checking your own work - Updating SharePoint - Tracking complaints in the process for closure - All other duties assigned EDUCATIONAL REQUIREMENTS: -
• Bachelor’s degree or equivalent experience - Generally requires 2 -4 years of related work experience - RAC or ASQ certification a plus Additional Information All your information will be kept confidential according to EEO guidelines.