Post-Market Regulatory Affairs Pro

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.

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.

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

Job description

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.