**Labeling Designer, Medical Device** **Colorado Springs, CO** **Type:** Contract **Category:** Regulatory/Compliance **Industry:** Life Sciences **Reference ID:** JN -022025-92609 **Date Posted:** 02/03/2025 **Shortcut:** http://careers.eliassen.com/oWxdTH + Description + Recommended Jobs **Description:** Hybrid role in Colorado Springs CO. In this role, you have the opportunity to bring your passion and energy into a growing department dedicated to the quality output of product labeling and packaging for Image Guided Therapy (IGT) devices in accordance with GMP’s, FDA Regulations, EUMDR, ISO Requirements and Standard Company Operating Procedures. In this role you have the opportunity to coordinate and assist with labeling/IFU creation and change management to our internal stakeholders. _Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance._ Rate: $35 - $55 / hr. w2 **Responsibilities:** + Creating IFU's for Medical Device labels + Establish project timeline based on external customer ask and resource availability and assign designer(s) + Work with internal and external customers to gather needs and requirements of labeling changes + Communicate gathered requirements to the design team and keep them informed of any late inputs/changes + Update and maintain all project logs, timeline management, and tracking through project life cycle. + Provide updates and status of design jobs to customers and project team through tracking, meetings, reports, etc. in a timely and detailed manner. + Review and proofread all packaging and labeling draft artwork to ensure accuracy while adhering to established company processes, client brand guidelines and labeling compliance standards. + Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments. + Will raise any designer staff or project issues and/or concerns to direct supervisor to immediately address, resolve and mitigate negative impact to the business. + Assist designers in processing translation job requests with vendors. Obtains cost and lead time quote estimates for approval by client for the purpose of localized packaging content + Maintain project management software (Monday.com) and prepare reports or dashboards as requested **Experience Requirements:** + Experience with Adobe Illustrator, InDesign and Photoshop + Experience with enLabel system software would be a plus + MDR Labeling experience, updates and submissions of change requests experience + Having IFU’s experience is a must _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact InfoSec@eliassen.com._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_