Careers

Regulatory Associate

 

Position overview:

The Regulatory Affairs Associate is responsible for core activities involving our MDR tracking and reporting . Additionally, the Regulatory Affairs Associate will perform other tasks in support of regulatory administration, ongoing compliance and corporate initiatives as required.

 

JOB / DUTIES / RESPONSIBILITIES

• Initiate MDR and Vigilance reports as, required and file timely MDRs.
• Manage internal regulatory files and organizational systems.
• Assist in the organizing and preparation of regulatory documents for submission to various regulatory agencies.
• Request certificates from FDA, as required.
• Prepare documents for registration.
• Support data analysis and interpretation of information.
• Other relevant duties as assigned by management.

JOB QUALIFICATIONS

• Administrative experience with database reporting and tracking of information is preferred
• Prior exposure to medical device industry is a plus.
• Must have analytical skills, be detail oriented and have good interpersonal skills.
• Strong computer skills
• Effective verbal and written communication skills
• Ability to generate and maintain accurate records
• Ability to work independently, managing workload and deadlines.

Qualified applicants please submit resumes to: careers@insulet.com