Senior Regulatory Affairs Lead, Medical Devices Submissions

Lancesoft; Chaska (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

LanceSoft is seeking a Senior Regulatory Affairs Specialist to plan, coordinate, and report on regulatory programs for Beckman Coulter products. The role focuses on post-market activities, complaint management, and global compliance strategies.

Responsibilities include preparing regulatory submissions (510(k), PMA) and coordinating cross-functional teams to support product labeling, data structuring, and promotional materials review.

Qualifications

• Bachelor's degree in a field related to Regulatory Affairs with 5+ years of experience or Master's with 3+ years.
• Medical Technologist background and IVD experience strongly desired.
• Regulatory affairs experience in medical devices and post-market activities.

Responsibilities

• Plan, coordinate, facilitate, and report on regulatory programs.
• Administer complaint management for compliance to corporate requirements.
• Plan and implement pre-market registrations and reporting.
• Support global regulatory compliance programs for action and adverse event reporting.
• Prepare regulatory submissions (510(k), PMA, technical dossiers) for US and other markets.
• Assist in creating clinical data and labeling for registration and commercialization.

Skills

Regulatory affairs

Cross-functional collaboration

Attention to detail

Project coordination

Education

Bachelor's degree in related field

Master's degree in related field

Medical Technologist background

Tools

510(k) submissions

PMA submissions

Technical dossiers

Job description

LanceSoft is seeking a Senior Regulatory Affairs Specialist to plan, coordinate, and report on regulatory programs for Beckman Coulter products. The role focuses on post-market activities, complaint management, and global compliance strategies.

Responsibilities include preparing regulatory submissions (510(k), PMA) and coordinating cross-functional teams to support product labeling, data structuring, and promotional materials review.