Description:
This role focuses on creating, reviewing, and managing labeling content for medical products, ensuring all materials meet medical, legal, and regulatory requirements. The Labeling Specification Specialist supports quality and regulatory compliance by maintaining accurate labeling data, coordinating UDI information in QMS Agile, and contributing to continuous improvement of labeling processes and quality systems. This position suits an established individual contributor who works independently on moderately complex projects and collaborates with cross-functional teams to deliver high-quality, compliant labeling.
Responsibilities
- Create, review, and reproduce text and artwork required for labeling medical products, ensuring accuracy and completeness.
- Ensure labeling art, film, and plate proofs comply with all applicable medical, legal, and regulatory requirements in the US and abroad.
- Monitor changes in labeling regulations and standards and incorporate updates into labeling content and processes as needed.
- Review promotional and commercial communication materials to confirm they are supported by appropriate data and align with approved applications.
- Monitor, evaluate, and recommend improvements to labeling processes, quality systems, tools, and policies to enhance efficiency and compliance.
- Coordinate and maintain UDI data within QMS Agile, including accurate data entry and ongoing data management.
- Support quality systems activities, including CAPA, change control, and validation-related labeling tasks.
- Assist with quality and regulatory audit activities related to labeling and documentation, providing required evidence and explanations.
- Deliver and manage assigned labeling projects from design through implementation while adhering to relevant policies and procedures.
- Collaborate with internal stakeholders to share status, requirements, and issues, and gather input to support decision-making.
- Apply specialized knowledge of medical device regulatory requirements to ensure labeling meets global regulatory expectations.
- Provide guidance and assistance to entry-level professionals or support staff involved in labeling and quality activities.
- Make recommendations for enhancements to systems and processes to solve problems or improve the effectiveness of the labeling function.
- Set objectives for assigned work to meet project milestones and contribute to broader project goals.
Essential Skills
- Experience with medical package labeling, including creation and review of labeling content for medical products.
- Experience with UDI data management, including data entry and coordination within QMS Agile or similar systems.
- Strong proofreading skills with exceptional attention to detail for reviewing labels and related documentation.
- Previous experience with quality systems and CAPA, including investigation, documentation, and follow-up activities.
- Experience with change control and validation processes within a regulated environment.
- Knowledge of medical device regulatory requirements and their application to labeling and promotional materials.
- Previous experience supporting quality and regulatory audit activities, particularly related to labeling and documentation.
- Practical knowledge and demonstrated competence in a professional discipline, typically obtained through advanced education and experience.
- University degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
- Ability to work independently with general supervision on moderately complex projects.
- Strong written and verbal communication skills for coordinating with internal stakeholders and documenting labeling activities.