Sr. Labeling Specialist - Shockwave Medical

Johnson & Johnson • Santa Clara, CA

3d • $91,000 - $147,200 • Onsite

About The Position

Johnson & Johnson is hiring for a Sr. Labeling Specialist – Shockwave Medical to join our team located in Santa Clara, CA . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Sr. Labeling Specialist is responsible for creating, designing, and releasing product labels and instructions for use (IFUs) that comply with applicable regulations (e.g., FDA/UDI, EU MDR/IVDR, ISO, etc.) This role partners with Regulatory, Quality, Supply Chain, R&D and Manufacturing Engineering to ensure accurate and compliant production labeling. The Senior Labeling Specialist leads complex labeling projects and manages cross-functional release and change-control activities.

Requirements

• Bachelor’s degree in life sciences, regulatory affairs, technical writing, communications, or related discipline; or equivalent combination of education and experience.
• 4–7 years of experience in medical device labeling, packaging, regulatory affairs, or quality systems; including experience managing IFU and label content changes under a QMS.
• Strong working knowledge of regulatory labeling requirements and industry-standard symbols and barcode/UDI formats.
• Exceptional attention to detail, excellent written communication and technical editing skills, project coordination skills, and ability to manage multiple priorities in a fast-paced environment.
• Proficiency with label/artwork file formats and MS Office (Word, Excel & Outlook); experience with Adobe Professional, label design software (Seagull Bartender), document control/PLM systems, and label proofing tools preferred.
• Ability to work collaboratively and independently while adapting to changing requirements.
• Ability to sit for prolonged periods (more than 2 consecutive hours in an 8-hour day), as needed.

Nice To Haves

• Agile Manufacturing
• Analytical Reasoning
• Brand Research
• Business Behavior
• Coaching
• Continuous Improvement
• Detail-Oriented
• Good Manufacturing Practices (GMP)
• Materials Handling
• Package and Labeling Regulations
• Package Equipment
• Plant Operations
• Problem Solving
• Process Control
• Product Packaging Design
• Quality Assurance (QA)
• Quality Management Systems (QMS)
• Safety-Oriented

Responsibilities

• Responsible for all product labeling in manufacturing, working with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to release new labels and implement updates to existing labels.
• Create, review, and proof label content, including text, barcodes, symbols, and instructions for use (IFUs), ensuring accuracy and compliance with regulatory and print specifications.
• Ensure label content meets country-specific regulatory requirements and standards (symbols, disposal, storage, lot/UDI requirements).
• Manage the full labeling change-control lifecycle, including change requests and cross-functional approvals within QMS.
• Maintain label master files and version control under QMS.
• Maintain labeling documentation within PLM, ERP, or document control systems.
• Support cross-functional labeling projects (e.g. new product introductions, technology upgrades, large-scale mass label updates, and special projects).
• Investigate and troubleshoot complex labeling or production-related labeling issues.
• Support verification and validation activities (e.g. proofs, print inspection
• Respond to labeling-related customer complaints and support CAPA activities.
• Adapt to various label design tools and administration systems and interfaces.
• Other duties as assigned.

Benefits

• This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
• Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level