POSITION SUMMARY:

Within the Operations team, the Regulated Labeling Specialist will help create, implement, and maintain the labeling development process within the Archer Quality Management System (QMS). The role is responsible for designing compliant product labeling and collaborating with key functions for proper implementation.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Development, implementation, execution of medical device labeling (labels, IFUs, inserts, etc.) processes
• Maintenance of labeling (labels, IFUs, inserts, etc.); track customer feedback/complaints as they pertain to labeling/product documentation; own all ECOs related to updates
• Creation of labeling requirements based on project goals, laws, regulations, and applicable standards
• Interact with key functions and project teams to gather product requirements for labeling development
• Work with team to ensure that labeling meets requirements for domestic and global submissions
• Interpret GTIN allocation rules into feedback for all new products and assess all changes for GTIN updates.
• Creation of source files and artwork for product labeling (commercial and clinical trial)
• Work closely with the manufacturing team for labeling implementation
• Project owner for labeling content translations:
  
  • Maintain translation vendor relationships
  • Work with commercial team for updates to translated documents
  • Maintain certificates of translation accuracy
• Execute against regional requirements and documentation needs for regions outside the United States. Advise teams on labeling requirements and drive labeling compliance through the QMS.
• Coordinate with internal and external resources, including but not limited to, medical/clinical/technical writers, translation services, and in-country representatives.
• Review international standards pertaining to labeling – incorporate updates as the standards change.
• Review, understand, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguard the privacy and security of protected health information and European Union personal data.
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.

EXPERIENCE:

• Proficiency in core Adobe Creative Suite design products: Photoshop, Illustrator, InDesign, or similar
• HTML and content management systems knowledge
• High proficiency with MS Office suite
• Experience with ISO 13485:2016 & 21CFR820 quality systems within regulated medical device space
• Working knowledge of the translation process
• Experience with third-party supplier management
• Detail-oriented with strong communication and organization skills
• Excellent eye for quality and sense of aesthetics
• Knowledge of medical device labeling standards such as ISO 28219, ISO 15223, and ISO 17100
• Project coordination/management experience
• Experience with Bartender labeling software a plus.

KEY ATTRIBUTES:

• Drive and determination
• Ability to work in a fast-paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Strong communication and presentation skills
  
  • Self-starter
  • Driven to perform
  • Self-directed: needs little explicit direction
• Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

EDUCATION:

• Minimum B.S./B.A. or equivalent experience (2-5 years)