Post Market Regulatory Affairs Specialist

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.