Documentation Specialist jobs in Indianapolis, IN

About Us

Intersurgical Inc. is a global leader in 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

At Intersurgical Inc. 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.

Purpose

As the Labeling & Documentation Specialist you will play a critical role in ensuring that our labels fufill company style and regulatory requirements.

You’ll have the opportunity to learn from the individuals that have played a part in building the business while helping thousands of people worldwide.

Responsibilities :

• Assist with ensuring labeling and directions for use comply with all applicable regulatory requirements
• Control labeling and Directions for Use accessible for production use
• Assist with preparing and maintaining labels and directions for use as directed
• Prepare and maintain labeling / IFU (Instructions for Use) charges as directed by Regulatory affairs department
• Coordinate and submit Engineering Change Notices upon request
• Distribution / notification activities after Engineering Change Notice approval if applicable
• Maintain Device Master Record (DMR) files
• Assist in maintaining company documentation and records
• Coordinate notifications of documentation required training as needed

What We’re Looking for

• 0-3 years experience in labeling and translations within the medical device industry
• Must be able to speak, read, and write English
• Competency in Microsoft Word, Adobe Acrobat and Excel

It Would Be Great If You Have

• In-depth understanding and experience with US FDA, CE and ISO Regulatory requirements
• Bachelor's degree in quality, risk management or related field
• SolidWorks Experience
• Adobe Indesign Experience

Requirements

• Temperature controlled facility with office and light manufacturing environment; non-smoking; safety hazards minimal; company provided smock and hairnet mandatory in all controlled production areas.

Intersurgical is 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.

• Competitive salary
• Multiple opportunities to be challenged and step up your career in a fast-growth company
• 401k match & profit sharing
• Paid Vacation and holidays
• Medical, dental, and vision benefits
• Much more...

Last updated : 2024-04-24