Regulatory Labeling and Documentation Specialist

Regulatory Labeling and Documentation Specialist

Location: Huntington Beach, CA

Compensation: $90,000 - $120,000 annually (depending on experience)

About the Role

At SprintRay, we are in a super-charged growth mode, constantly innovating while maintaining the highest quality standards for our products and processes. Our mission is to deliver safe, reliable, and innovative medical devices to improve patient outcomes.

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

About SprintRay

SprintRay is rewriting the rules of dentistry with technology that's smart, fast, and designed to make life easier for dental professionals. Since 2014, we've been on a mission to deliver the most advanced 3D printing solutions in the industry-combining hardware, software, and materials into one seamless ecosystem.

But what really makes SprintRay different is our people. We're a bold, global team of innovators, problem-solvers, and doers who thrive on pushing boundaries and challenging the status quo. Every product we create is driven by a simple goal: help dentists spend less time on repetitive tasks and more time changing patients' lives.

Our culture is entrepreneurial, collaborative, and fueled by curiosity. We celebrate diverse perspectives and believe the best ideas can come from anywhere. Whether we're building next-generation AI tools, designing new materials, or supporting our customers on the front lines, we're united by the same passion-transforming digital dentistry and having fun while we do it.

At SprintRay, the future of dentistry is being printed today. Want to be part of it?

Equal Opportunity Employer

SprintRay is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

To All Recruitment Agencies:

Without a written agreement signed by an officer of SprintRay: a) SprintRay does not accept resumes from recruiting agencies, headhunters, or any other party expecting payment in the event SprintRay speaks with or hires a candidate from such submitted resume; b) SprintRay is not responsible for any fees related to unsolicited resumes or related Terms of Service, and c) Unsolicited resumes received will be considered the property of SprintRay and will be processed accordingly.

Accessibility

If you need a reasonable accommodation during the application or interview process, please contact us at people.services@sprintray.com.