Post Market Regulatory Affairs Specialist

LanceSoft Inc; West Chester (Chester County); On-site; USD 70,000 - 95,000; Full time

Job summary

A medical regulatory company is seeking a Post Market Regulatory Affairs Specialist in Chester County, West Chester to oversee complaint handling and regulatory submissions. This role requires strong communication skills, detailed orientation, and the ability to work in a matrix environment. A Bachelor’s degree and 2-4 years experience are essential. Responsibilities include regulatory reporting, interfacing with partners, and achieving productivity targets in compliance with regulations.

Qualifications

• Bachelor’s degree or equivalent experience.
• 2–4 years of related work experience.
• RAC or ASQ certification a plus.
• Strong verbal and written communication skills.

Responsibilities

• Responsible for on-time submission and accuracy of regulatory reports.
• Review and complete determination associated Medical Device Report.
• Interface with service centers, Hospitals, Surgeons for reporting.
• Achieve productivity and accuracy targets for complaint documentation.
• Participate in projects and events related to complaint handling.
• 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
• Updating SharePoint
• Tracking complaints in the process for closure
• All other duties assigned

Skills

Problem solving/root cause analysis skills

Strong verbal and written communication skills

Detail orientation

Critical thinking skills

Collaboration and teaming skills

Proficiency in MS Office

Ability to work in a cross-functional matrix environment

Education

Bachelor’s degree or equivalent experience

Generally requires 2-4 years of related work experience

RAC or ASQ certification

Tools

MS Office

Job description

Post Market Regulatory Affairs Specialist

Full-time

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

All your information will be kept confidential according to EEO guidelines.