Regulatory Affairs Specialist

Integrated Resources, Inc ( IRI ); Chaska (MN); On-site; USD 110,000 - 170,000; Full time

Job summary

Integrated Resources, Inc (IRI) seeks a Senior Regulatory Affairs Specialist to lead evaluation, coordination, and execution of post‑market regulatory activities for medical devices in the United States and globally. The role emphasizes adherence to corporate regulatory requirements and cross‑functional collaboration.

The ideal candidate will have a strong background in regulatory submissions (510(k), PMA) and experience guiding pre-market activities.

Qualifications

• Bachelor’s degree in field with 5+ years exp.
• Master’s degree in field with 3+ years exp.
• Medical Technologist background strongly desired.

Responsibilities

• Administer the company's complaint management program to ensure compliance with corporate requirements.
• Plan and implement pre-market registration, reporting and compliance activities per development center business plans.
• Implement global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Prepare premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
• Assist technical departments, manufacturing centers and suppliers in creating and structuring clinical data for pre-market notifications.
• Serve as a team expert for review of promotional materials, experimental designs, data analysis and labeling related to registration and commercialization of medical devices.

Education

Bachelor’s degree in field

Master’s degree in field

Medical Technologist background

Job description

The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Client regulatory programs.

The incumbent’s primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.

Responsibilities

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 with 3+ years exp.

Preferred Background

• Medical Technologist background strongly desired.