Regulatory Labeling and Documentation Specialist
Location: Huntington Beach, CA
Compensation: $90,000 - $120,000 annually (depending on experience)
About the Role
We are seeking a detail-oriented specialist to join our QA/RA team. This role helps keep our medical devices compliant in the US, EU and all MDSAP regions, and keeps our quality documentation accurate, current and audit-ready.
Key Responsibilities
• Prepare and maintain medical device labels and IFUs:
• Author, revise and format device, carton, packaging and UDI labels, IFUs, and user manuals for new products and product changes
• Translate design inputs, risk management outputs (ISO 14971) and usability findings into clear warnings, precautions and contraindications
• Build country-specific labeling content, including language, symbol, format and local statements
• Coordinate translations with approved vendors and in-country reviewers, and verify translated labeling before release
• Manage eIFU content and website postings per applicable requirements (e.g., EU Regulation 2021/2226)
• Prepare and verify UDI data for FDA GUDID, EUDAMED and other national UDI databases
• Maintain labeling specifications and artwork files, and review artwork proofs and print samples against them
• Verify that each product label matches the Safety Data Sheet (SDS) for each country, including hazard statements, pictograms, precautionary statements and product identifiers
• Support QMS document routing and review:
• Initiate, route and track document change requests and change orders through the electronic QMS
• Route SDSs for each country through the QMS for review and approval
• Review SOPs, work instructions, forms, specifications and labeling records for format, completeness and compliance before approval
• Confirm approvers, effective dates and revision histories for released documents
• For each new or revised document, identify the people who need training using the training matrix
• Send and organize the required training, and track completion so training is in place by the effective date
• Maintain DMR / Medical Device File labeling sections
• Identify bottlenecks in document workflows and propose improvements to templates and routing
• Communicate labeling and document updates:
• Notify the partner team of new or revised labels and documents
• Ask the partner team to relay the updates to the proper parties, such as distributors and Notified Bodies, and confirm the information was received
• Ensure global labeling compliance:
• Maintain a labeling requirements matrix by market and update it as regulations and standards change
• Run labeling compliance assessments for new products, market expansions and change orders
• Support labeling sections of 510(k)s, EU MDR technical documentation and Health Canada, ANVISA, TGA and PMDA filings
• Review promotional and marketing materials for consistency with cleared or approved labeling
• Help qualify and approve new distributors by collecting and reviewing their qualification documents and quality agreements.
• Support CAPAs, recalls, field actions and labeling-related corrections.
• Support internal audits, MDSAP and Notified Body audits, and FDA inspections by presenting labeling and document control records.
• Assist QA/RA colleagues with complaints, supplier quality, training records and submissions, and provide backup for document control when needed.
• Performs other related duties and projects as business needs require at direction of management.
Required Labeling Knowledge
• United States (FDA):
• 21 CFR 801 (incl. Rx labeling 801.109), 21 CFR 830 UDI / GUDID, 21 CFR 820 QMSR labeling controls
• European Union:
• MDR 2017/745 Annex I Chapter III and Article 27 UDI, eIFU Regulation 2021/2226, EUDAMED
• Language requirements of each member state
• MDSAP jurisdictions:
• Canada: Medical Devices Regulations SOR/98-282, ss. 21-23; English and French
• Brazil: ANVISA RDC 751/2022; Portuguese
• Australia: Therapeutic Goods (Medical Devices) Regulations 2002, Essential Principle 13
• Japan: PMD Act package insert requirements; Japanese
• Other markets:
• UK (MHRA / UKCA), Switzerland (Swissmedic) and distributor markets as added
• SDS / hazard communication:
• Working knowledge of country SDS rules (e.g., OSHA HazCom, EU CLP, Canada WHMIS) and UN GHS to check label-SDS consistency
• Standards:
• ISO 15223-1, ISO 20417, ISO 13485, ISO 14971, IEC 62366-1 and IEC 60601-1 (marking)
Required Qualifications
• Bachelor's degree in life sciences, engineering, regulatory affairs, technical communication or a related field
• 3-5 years of experience in the medical device industry, with at least 2 years authoring or managing medical device labeling and IFUs
• Hands-on labeling experience for US and EU MDR markets, plus at least one other MDSAP jurisdiction
• Working experience with document control in an ISO 13485 QMS, including change control and approval routing
• Experience with UDI implementation and database submissions (GUDID, EUDAMED)
• Familiarity with SDS content and GHS hazard communication
• Exceptional attention to detail, with the ability to catch errors in text, symbols, barcodes and translations
• Strong technical writing skills, with the ability to turn engineering and risk data into plain user instructions
• Strong prioritization and organization skills to manage many labeling projects and document routes at once
• Ability to work cross-functionally with R&D, Marketing, Operations, Supply Chain and external partners
• High level of integrity, trustworthiness, and confidentiality
Preferred Qualifications
• Experience with dental medical devices
• Experience labeling OEM, private-label or distributor-supplied products
• Experience supporting MDSAP or Notified Body audits
Employment Type
Fulltime, Onsite
