Labeling and Documentation Specialist

About Us

Engineered Medical Systems, an Intersurgical Inc. company, 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

To manage labeling activities and labelling information in the group, to ensure that labels fulfill company style and regulatory requirements. Responsible for maintaining and organizing the companies’ documentation and records.

Key Responsibilities

Labeling

•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 by RA Manager

•Cooperate with Regulatory Affairs Manager when investigating complaints or internally found abnormalities related to labeling.

•Prepare and maintain labeling and IFU/DFU artwork changes as directed by RA Manager

•Assist RA Manager in new product labeling development

•Assist production department and quality department with incoming and stock label development

•Releasing and pulling of labeling and IFU/DFU revision change for production use

Documentation & Records

•Coordinate and submit Engineering Change Notices for labeling and DFU/IFU

•Distribution/notification activities after ECN approval if applicable

•Releasing of approved documentation for production use

•Support production with documentation, supply documents request for production workorders

•Coordinate with production for revision changes, pulling previous revision / workorders and the release of new revision / workorders

•Maintain Device Master Record files in PDM

•Assist with maintaining company documentation and records

•Coordinate notifications of documentation required training as needed

Qualifications & Skills

• 3 years of experience and/or education in related field, for labeling and translations within the medical device industry.

• Must be able to speak, read and write English

• In-depth understanding and experience with US FDA, CE and ISO Regulatory requirements

• Ability to work independently and cope with changing priorities, and to prioritize workload to meet datelines

Requirements

• Must be able to speak, read, and write English fluently

• Must be able to sit, stand, and/or walk for extended periods

• Occasionally required to lift up to 50 lbs. when handling returned orders or documents

Work Environment

• Temperature-controlled facility with office and light manufacturing areas

• Non-smoking environment with minimal safety hazards. Some exposure to chemical substances in manufacturing areas, but direct handling is not required

• Company-provided smock and hairnet are mandatory in all controlled production areas

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.

• 💰 Competitive salary
• 🧠 Multiple opportunities to be challenged and step up your career in a fast-growth company
• 📈 401k
• 🏖️ Paid Time Off and holidays
• 😌 Medical, dental, and vision benefits
• 👀 Much more...