Labeling Specialist - Medical Device

About the role

The Document Control Specialist II is responsible for managing controlled documentation and product labeling throughout the product lifecycle within a regulated medical device environment. This role supports the creation, revision, approval, publication, and maintenance of product labeling, Instructions for Use (IFUs), packaging artwork, and other regulated documents.

Responsibilities

• Administer document control activities in accordance with company procedures and regulatory requirements.
• Process creation, revision, review, approval, distribution, and archival of controlled documents.
• Maintain document history records and ensure traceability of document changes.
• Support periodic document reviews and document retention activities.
• Ensure documentation complies with FDA 21 CFR Part 820, ISO 13485, MDR, and internal quality system requirements.
• Manage document workflows within electronic document management systems (eDMS).
• Coordinate development, review, approval, and release of product labeling materials, including:
• Product labels
• Instructions for Use (IFUs)
• Packaging inserts
• Multi-language labeling
• Carton and pouch artwork
• Electronic labeling content
• Perform proofreading and quality checks for labeling accuracy, formatting consistency, and regulatory compliance.
• Support change control activities impacting labeling and packaging documentation.
• Ensure implementation of approved labeling changes across manufacturing and distribution operations.
• Author, edit, and maintain labeling content using XML-based structured authoring systems.
• Support content reuse strategies, modular content development, and single-source publishing initiatives.
• Generate and publish labeling deliverables for global markets.
• Partner with Regulatory Affairs and Technical Writing teams to maintain content consistency and compliance.
• Participate in document and labeling-related audits and inspections.
• Affiliate with CAPA activities, investigations, and quality initiatives related to documentation or labeling processes.
• Provide guidance and training to document authors on document control and labeling procedures.
• Support continuous improvement initiatives focused on documentation efficiency and compliance.

Requirements

• Minimum 3 years of experience in document control, labeling, technical publications, or content management within a regulated industry.
• Working knowledge of FDA, EU MDR, ISO 13485, and document control best practices.
• Experience managing controlled documents through electronic Quality Management Systems (eQMS) or eDMS platforms.
• Experience with XML-based authoring tools such as: Adobe Experience Manager (AEM), IXIASOFT CCM, SSDL/Tridion Docs, Oxygen XML Editor, Arbortext, MadCap Flare (structured content environments).
• Advanced proficiency with Adobe InDesign.
• Experience supporting multilingual content and labeling workflows.
• Strong Microsoft Office Suite skills.

Qualifications

• Medical device labeling and artwork management.
• Structured authoring and single-source publishing.
• Global product labeling and translation management.
• Regulatory submissions support related to labeling content.
• Quality systems and change control management.

Skills

• Exceptional attention to detail.
• Strong proofreading and editing skills.
• Excellent organizational and document management capabilities.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Strong communication and cross-functional collaboration skills.
• Demonstrated ability to work independently and exercise sound judgment.

Benefits

• Medical, dental & vision coverage.
• Critical Illness, Accident, and Hospital coverage.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents).
• Short and long-term disability coverage.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time Off/Leave (PTO, Vacation or Sick Leave).

Pay and Benefits

The pay range for this position is $28.00 - $34.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available.

Job Type & Location

This is a Contract position based out of Tampa, FL.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.