Global Labeling Manager, Regulatory Affairs

ABOUT ORGANOX

OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra®. This technology helps preserve donor livers for up to 12 hours (US) or 24 hours (Canada/EU/UK), in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Global Labeling Manager to join our team.

Position Summary

The Global Labeling Manager will ensure the timely and accurate delivery of product labeling. This position will work with both internal and external stakeholders to support the labeling needs for new product launches and updates to existing products.

This role will report directly to the VP of Global Regulatory Affairs.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the VP of Global Regulatory Affairs.

Major Responsibilities

• Under direction from the VP of Global Regulatory Affairs, the Global Labeling Manager will:
• Lead and strategize on new product labels for medical devices from concept to completion
• Effectively work with cross-functional team (e.g. R&D, Regulatory, Operations, Quality, Marketing) to develop labeling that meets the requirements of the FDA and international regulatory agencies, internal brand/design requirements, and manufacturing specifications.
• Maintain medical device product labels in compliance with global regulations and standards, including FDA, EU MDR, and others
• Establish and drive deadlines to meet project deliverables
• Review and approve product label artwork, ensuring alignment with regulatory requirements and company standards
• Stay current with product label regulations and industry trends to provide guidance and recommendations to the organization
• Assist with writing and maintaining work instructions regarding the device label process and procedures
• Participate in audits and inspections related to product label processes and documentation
• Complete assessments for sustaining projects to identify scope and impact to labeling
• Manage the translation of packaging and labeling items with translation supplier
• Support regulatory submissions through the delivery of draft and final labeling
• Manage assigned projects within assigned resources
• Train, develop and mentor individuals; may include formal supervisory responsibilities
• Author regulatory response documents for package component labeling responses
• Support labeling deviations and CAPA's related to labelling
• Accountable for oversight of compliance with labeling processes and supporting associated regional labelling for inspection readiness
• Management of Regulatory Information Management System
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies
• This role may require travel up to 15%.

Skills and Experience

Working knowledge of global/regional regulations and guidelines pertaining to labeling

Ability to decipher and understand implications of label changes on pending and approved labels across regions

Ability to liaise with stakeholders using effective means of communication and influence/negotiate where necessary

Experience in cross-functional collaboration with Quality, Marketing, Clinical Affairs, Manufacturing, and R&D

Fluent in English language; multi-language skills are advantageous

Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint)

Excellent verbal and technical writing skills

Ability to work independently

Qualifications

The Global Labeling Manager will have:

• A bachelor’s degree in pharmacy, life sciences, engineering or related subject
• At least 7 years’ experience in medical device industry implementing successful global labeling strategies is preferred
• The ability to operate in a fast developing and changing environment, able to differentiate and prioritize between multiple competing options, without losing sight of the long-term strategic objectives of the company
• Experience with Class II and III medical devices

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

WHAT WE OFFER

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.