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Associate Medical Device Labeling Jobs in Colorado

Three Point Solutions

Graphic Designer

Lafayette, CO · On-site

$40 - $45/hr

... Medical Device Labeling • IFU (Instructions for Use) Documentation • Technical Documentation • Regulated Industry Documentation • Packaging Artwork Support • Quality Review & Compliance ...

Rep-Lite

SPD Field Account Specialist - 61

Denver, CO · On-site

Associate Medical Device Representative * Scrub Tech or candidates with orthopedic or technical device exposure Education & Certifications * Associate's degree preferred, not required * CRCST / CBSPD ...

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Associate Medical Device Labeling information

What are some common challenges faced by Associate Medical Device Labeling professionals, and how can they be addressed?

Associate Medical Device Labeling professionals often encounter challenges such as keeping up with evolving regulatory requirements across different countries, ensuring accuracy and clarity in complex technical information, and coordinating input from multiple departments like regulatory affairs, engineering, and marketing. Addressing these challenges involves staying updated on global labeling standards, developing strong attention to detail, and building effective communication and collaboration skills. Leveraging project management tools and regularly participating in training can also help manage these complexities and ensure timely, compliant labeling deliverables.

What are Associate Medical Device Labeling professionals?

Associate Medical Device Labeling professionals are responsible for creating, reviewing, and maintaining the labeling and packaging materials for medical devices. Their work ensures that all product information, instructions, and regulatory warnings are accurate, clear, and compliant with industry regulations. They collaborate closely with regulatory affairs, quality assurance, and product development teams to make sure that labels meet local and international standards. This role is critical in helping ensure patient safety and regulatory approval of medical devices.

What are the key skills and qualifications needed to thrive as an Associate Medical Device Labeling Specialist, and why are they important?

To thrive as an Associate Medical Device Labeling Specialist, you need a strong understanding of regulatory requirements, attention to detail, and experience in technical writing, often supported by a degree in life sciences or a related field. Familiarity with labeling software, document management systems, and knowledge of FDA or EU MDR regulations are typically required. Excellent communication, collaboration, and organizational skills set top performers apart in this position. These skills are crucial to ensure label accuracy, regulatory compliance, and patient safety in a highly regulated industry.
What cities in Colorado are hiring for Associate Medical Device Labeling jobs? Cities in Colorado with the most Associate Medical Device Labeling job openings:
Associate Medical Device Labeling jobs near you
Labeling Designer (Medical device)

Labeling Designer (Medical device)

APN Software Services, Inc

Colorado Springs, CO • On-site

Other

Posted 7 days ago

Job description

Labeling Designer (PHIAJP00004041)

Duration: 12 months

Location: Colorado Springs, CO
From the manager: If you can find a candidate that has design and project management experience, that would be very beneficial.
You are responsible for ·
Develop and maintain Instruction For Use (IFUs) documents, including product illustrations, layout design, and illustrative material and copy.
Utilize existing templates in programs including, but not limited to, Bartender, Adobe LiveCycle and EnLabel to create or revise labeling artwork and content based on corporate graphic standards, procedures and/or previously established formats.
· Use of PLM (Windchill) for document control process to route all work for approval
· Perform prepress activities necessary to prepare labeling artwork files for accurate output.
· Prepare and route labeling packages for 1st article and approvals.
· Proofread labeling artwork utilizing measurement, inspection tools (e.g. rulers, barcode scanner, etc.) and related documentation. This is a quality role in medical devices which focuses on a first-time right approach. Attention to detail with minimal errors is key.
· Reviews and updates as necessary to ensure proper revision control and storage of all labeling.
· Establishes and cultivates a network of support (manufacturing, engineering, regulatory, legal, product development and marketing) to facilitate completion of labeling and artwork assignments.
· Can successfully work with cross-functional teams to address NCRs and CAPAs. Investigate, analyze, and identify root cause. Evaluate underlying issue and find long-term solutions.
· Maintains and follows proper compliance and quality system requirements. Ensures proper documentation is prepared and corrected to reflect continuous improvement activities that lead to new or improved processes.
You are a part of A recently restructured organization dedicated to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact within the team, our business, and health technologies that will improve the health, well-being and care for people around world. Additionally, we believe that people are #1 and are intentional about creating a culture that reinforces that.
To succeed in this role, you should have the following skills and experience
· Bachelors degree or equivalent relevant experience required
· Proficient in Adobe Creative Suite and Microsoft Office
· Experience with Adobe Lifecycle is preferred
· Exposure to Bartender, EnLabel, Windchill and/or SAP is a plus
· Knowledge of Regulatory standards (FDA, EU MDR, Japan, Canada, ISO standards) is preferred
· Excellent written and verbal communication skills
· Ability to exercise independent judgment consistent with company policy
· Ability to organize and prioritize workflow
· Ability to interact with all levels of employees including senior management
· Ability to adapt to changing processes and learn programs/software quickly
· Strong attention to detail is critical.

Thanks, 

Amit Sehdev

APN Software Services Inc.

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