About Us
Insulet is looking for a Regulatory Affairs Specialist to join this dedicated, growing team. This person should have a minimum of 2 years experience in the medical device industry with a BA or equivalent experience.
Position overview: The Regulatory Affairs Specialist is responsible for activities which support domestic and international regulatory registrations, submissions, and reporting activities, including data and information analysis. Additionally, the Regulatory Affairs Specialist will perform other tasks in support of ongoing compliance and corporate initiatives as required.
Position overview: The Regulatory Affairs Specialist is responsible for activities which support domestic and international regulatory registrations, submissions, and reporting activities, including data and information analysis. Additionally, the Regulatory Affairs Specialist will perform other tasks in support of ongoing compliance and corporate initiatives as required.
JOB / DUTIES / RESPONSIBILITIES (Listed in order of importance)
- Establish internal systems for regulatory approval of medical devices in international market. Compile and submit documentation as required in support of marketing initiatives.
- Assist in the planning, organizing and interpreting of regulatory documents for submission to various regulatory agencies.
- Support data analysis and interpretation of clinical information.
- Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.
- Review product design and / or process changes for affect on regulatory submissions.
- Recommend changes for labeling, manufacturing, and marketing for regulatory compliance.
Requirements
- B.S. / B.A. or equivalent combination of education and experience.
- RAPS Certification (RAC) is preferred.Minimum 2 years of medical device industry experience.
- Experience in dealing directly with FDA and/or foreign regulatory bodies is highly desired.
- Must have analytical skills, be detail oriented and have good interpersonal skills.
- Knowledge of federal guidelines and international requirements preferred.
- Effective verbal and written communication skills
If you of someone you know is interested in this challenging and rewarding position, please submit an updated resume to Jessica Carreiro at jcarreiro@insulet.com.
