Regulatory Affairs Specialist (Indianapolis)

About Us

Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care and medical device manufacturing. We partner with providers, manufacturers and other organizations to supply innovative airway and medical devices that impact the lives of patients every day. Driven by our commitment to supply high quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.

Our Culture

We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic selves. We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view you'll bring to the table while fostering a spirit of communication.

Job Overview

Primary responsibility is assisting with activities pertaining to the submissions and communications with regulatory authorities such as Food and Drug Administration and other local or regional bodies. Assist with generating, coordinating and maintaining documentation required to allow products to be marketed in the USA.

Key Responsibilities

• Support the assessment activities for determining the regulatory path for new devices
• Support preparation, documentation and submission activities for regulatory submissions for US market
• Prepare the documentation for justification when no submission is required for regulatory clearance.
• Maintain regulatory compliance records for devices
• Assist with maintaining current regulatory status for devices on the market
• Participate in the assessment of device changes for regulatory implications
• Prepare reports and documents to support regulatory submissions for changes when required
• Assist in ensuring product labeling, advertising, and promotional materials comply with FDA regulations
• Provide back-up support for other roles, as necessary. Other duties as assigned by the manager / supervisor

Qualifications & Skills

Requirements

Work Environment

We are an Equal Opportunity Employer that takes pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.

Benefits

We are passionate about the well-being of others and that begins with caring for our people.