Document Control Records Management - Regulatory Affairs Specialist - Senior

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

Enter Job Description... The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Beckman Coulter regulatory programs. The incumbent s primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.

Responsibilities may include:

• Administration of the company's complaint management program for compliance to corporate requirements
• Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
• Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
• Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
• Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

Educational requirements: Bachelor s degree in field with 5+ years exp. OR Master s degree in field with3+ years exp. Medical Technologist background and IVD experience strongly desired.

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer.

We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.