Regulatory Affairs Manager – Labeling

This is a fully remote position, open to applicants in Illinois, +3 more states.

📋 Description

• Develop, execute, and sustain a unified global labeling strategy across various product lines and markets.

• Oversee the complete labeling lifecycle, which includes the creation, review, approval, and maintenance of labeling content and artwork within a controlled Quality Management System.

• Stay updated on global regulatory changes and evaluate their implications for product labeling.

• Ensure that product labeling adheres to global medical device regulations and international standards.

• Spearhead the implementation and upkeep of Unique Device Identification (UDI) requirements.

• Supervise the proper application of harmonized symbols, safety warnings, contraindications, and necessary labeling content.

• Manage labeling requirements specific to countries, including translations, health authority marks or logos, and formatting mandates.

• Ensure the accurate application of environmental symbols, sustainability marks, and packaging material identification.

• Oversee labeling requirements pertaining to REACH, RoHS, WEEE, California Proposition 65, and EU MDR.

• Formulate strategies for new requirements such as PPWR, repairability scores, and electronic or digital labeling.

• Collaborate with R&D, Packaging Engineering, Supply Chain, Marketing, and Graphic Design teams.

• Incorporate labeling controls into design controls, change control, risk management, and supplier management processes.

• Engage in the development of policies and procedures, and suggest new practices, processes, metrics, or models.

• Lead complex, large-scale projects and independently decide on methods for initiating new projects.

• Mentor junior colleagues.

⛳️ Requirements

• A Bachelor’s degree in scientific, engineering, life sciences, or a related field is preferred, or equivalent work experience.

• 7-10 years of experience in a Regulatory Affairs role within the medical device sector is preferred.

• Proven experience in global medical device labeling, including labeling content, IFUs, and artwork within a regulated environment is preferred.

• Experience in interpreting and applying REACH, RoHS, WEEE, and PPWR to product labeling requirements is desired.

• Comprehensive knowledge of labeling requirements for the US, EU, Canada, Japan, and Australia is preferred.

• Exceptional attention to detail.

• Ability to foresee regulatory trends and develop proactive compliance strategies.

• Strong organizational and project management skills.

• Demonstrated ability to lead through influence, build consensus, and drive decisions across cross-functional teams.

• Ability to apply ISO 14971 risk management principles to labeling.

• Excellent written and verbal communication skills.

• Advanced knowledge of relevant concepts, principles, and technical capabilities.

• An advanced degree or Regulatory Affairs Certification (RAC) is a plus.

🏝️ Benefits

• Bonus eligible.

• Medical, dental, and vision coverage.

• Paid time off plan.

• Health savings account (HSA).

• 401k savings plan.

• Access to wages before payday with myFlexPay.

• Flexible spending accounts (FSAs).

• Short- and long-term disability coverage.

• Work-Life resources.

• Paid parental leave.

• Healthy lifestyle programs.

• An inclusive workplace that values diversity of thought, experience, and background.