Labeling Specialist - Medical Device

Job Title: Document Control Specialist

Document Control

Specialist II - Labeling & Structured Content Management

Position Summary

The Document ControlSpecialist 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.

The ideal candidate will possess experience with XML-based authoring tools, Adobe InDesign, document management systems, and quality management processes within FDA, EU MDR, and ISO 13485 regulated environments. This individual will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, Engineering, Marketing, and Manufacturing teams to ensure labeling content is accurate, compliant, and effectively controlled.

Essential Duties and Responsibilities

Document Control

• 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).

Labeling & Artwork

Management

• 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.

Structured Content Authoring

• 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.

Cross-Functional Support

• Participate in document and labeling-related audits and inspections.
• Assist 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.

Required Qualifications

• Minimum 3 years of experience in document control, labeling, technical publications, or content management within a regulated industry.
• Experience in the medical device, pharmaceutical, biotechnology, or diagnostics industry preferred.
• 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.

Technical Skills Required

• Experience with XML-based authoring tools such as:
  • Adobe Experience Manager (AEM)
  • IXIASOFT CCMS
  • SDL/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.

Preferred

• Experience with content management systems (CCMS).
• Experience with artwork approval systems and labeling management platforms.
• Familiarity with UDI requirements and global labeling regulations.
• Experience with Adobe Illustrator and Acrobat Pro.
• Knowledge of translation management workflows and localization processes.

Competencies

• 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.

Preferred Experience

• 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.

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

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: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Jul 27, 2026.

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.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $28 - $34