Staff Regulatory Labeling Specialist
Location: Remote, Allendale, NJ or Leesburg, VA
Company: VB Spine
Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures.
As a Staff Regulatory Labeling Specialist, you’ll play a key role in supporting labeling and Instructions for Use (IFU) requirements to ensure global product compliance and distribution for medical devices.
In this individual contributor role, you’ll be expected to work independently, using sound judgment to apply professional expertise and drive assignments for yourself and your function. You’ll be responsible for developing and maintaining compliant labels and IFUs, collaborating with product subject matter experts to gather and assess content, and promoting best practices and standardization across our global business.
You’ll review labeling and IFU change information to ensure data integrity and consistency with application requirements. Using specialized software, you’ll execute formatting and compile content while ensuring compliance with global medical device regulations, industry standards, and business needs.
As a subject matter expert (SME), you’ll also train, mentor, and guide the labeling team and other functions on best practices related to labeling and IFUs. Candidates should ideally be located in Allendale, NJ or Leesburg VA.
What You’ll Do:
- Own and drive the best practices for label/IFU design and implementation for VB Spine.
- Fully understand and be able to apply global labeling standards and regulations. Additionally, be able to coach and mentor others on the team in this area of expertise.
- Analyze labeling standard updates to identify gaps in labeling/IFU and/or procedures.
- Assess impact on proposed label/IFU changes.
- Collaborate with product and cross-functional SMEs to assess and determine label requirements and content.
- Work with external suppliers to review and approve supplier generated labels.
- Design label formats for functional usability by healthcare staff according to requirements based on global markets.
- Support multiple concurrent, complex labeling projects for new products, mergers and acquisitions, and label maintenance
- Ability to implement best practices to address an issue, gap or strategy. Looks to generate process improvements that impact the labeling/IFU process to more efficiently impact the organization.
- Participate in new product label planning meetings and capture requirements using quality system planning documents.
- Drive and lead innovation and strategic labeling/IFU initiative projects.
- May be the Process Owner for labeling and IFUs.
- Manage translation process/procurement and quality of translated documents.
- Support label translation strategies that satisfy international labeling needs.
- As needed, own and drive any applicable NC/CAPAs to closure.
- Review labels for completeness and presentation including labels created by others.
- Contact external suppliers to resolve label output details.
- Manage labels in PLM and/or ERP system for controlled label releases and revision management.
- Manage work to meet project milestones.
- Inform project managers of relevant aspects of language translation and impact to label design.
- Initiate/assist with departmental continuous improvement endeavors.
- Collect and track data/metrics associated with projects.
- Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements.
- As needed, publication and/or uploading of approved documents to eIFU website.
- As needed, assist with regulatory audits.
- Measure project performance using appropriate tools and techniques to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders
- Utilize and comply with VB Spine’s Quality Management System including proactively verifying if requirements are met.
What You Bring:
- B.S. or B.A. Required
- 5+ years of experience in medical device labeling and/or regulatory affairs
- Excellent verbal, written and interpersonal communication skills. Ability to communicate effectively with team members, management, and subject-matter experts.
- Must be able to demonstrate attention to detail and complete high quality, detailed documentation accurately under compressed and competing timelines, following Good Documentation Practices (GDP).
- General understanding of other related disciplines (i.e. risk management, product safety, clinical sciences, etc.).
- Ability to work independently and motivated to perform at a high-level without constant supervision.
- Proven ability to implement medium to large scale projects.
- Ability to generate and explain detailed schedules and performance objectives.
- Customer service oriented. Able to work with internal teams and external services.
- Ability to problem solve and provide solutions to a variety of technical problems of moderate scope and complexity where analysis of situations and strategy for labeling requires a review of a variety of factors.
- Experience developing deliverables for language translation to a global audience.
- Experience with application of domestic and international regulatory requirements; and standards and guidance pertaining to medical device labeling requirements governing medical device labeling (e.g. FDA, EU MDR).
- Experience working cross-functionally with medical device engineering, marketing regulatory, clinical, legal teams.
- Hands-on experience with database compilation labeling systems (i.e., Robar).
- Experience working within PLM.
- Strong working knowledge of Microsoft Office, Teams, Adobe Acrobat Pro, Adobe Illustrator etc.
- Experience working with component content management systems related to the modular reuse of content.
- Experience with generating eIFUs and publishing to eIFU website.
- Experience supporting audits.
Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and shape strategy in the dynamic field of medical sales—positioning yourself to influence growth and innovation across the organization.
Compensation:
Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $95,000.00 - $140,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.
Benefits include:
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company