Regulatory Affairs Manager

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, in efforts to reduce organ discard rates and facilitating 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 Regulatory Affairs Manager to join our team.

Position Summary

The position of Regulatory Affairs Manager will work with internal and external partners to deliver innovative products to customers through the preparation of comprehensive regulatory strategies and submissions to achieve marketing approvals in North America.

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.

Requirements

Major Responsibilities

Under direction from the VP of Global Regulatory Affairs, the Regulatory Affairs Manager will:

• Prepare regulatory strategies for New Product Development and Sustaining projects to enable marketing approvals
• Develop and manage content for regulatory submissions, including clinical trial applications (i.e., IDEs), new marketing applications and supplements
• Manage products and change controls in compliance with regulations and company policies and procedures
• Represent Regulatory Affairs on teams such as product development, Clinical, Quality, Marketing and Operations to negotiate, influence, and provide strategic advice
• Manage assigned projects within assigned resources
• Seek expert advice and technical support as required for strategies and submissions
• Regularly inform regulatory management of important timely issues
• Train, develop and mentor individuals
• Coordinates planned regulatory submissions with ONA Regulatory team
• Develop and implement policies and procedures within the regulatory affairs department
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

This role will require travel up to 20%.

Skills and Experience

• Proven track record of achieving regulatory approval
• Working knowledge of FDA and Health Canada processes for Class II and Class III medical device marketing approval
• Experience in effectively leading a team of regulatory professionals
• Ability to write clear regulatory strategies and submissions
• Experience in cross-functional collaboration with Quality, Clinical Affairs, Manufacturing, and R&D
• Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint)
• Excellent verbal and technical writing skills
• Ability to work independently

Qualifications

The Regulatory Affairs Manager will have:

• A BS degree in life sciences, engineering or related subject
• At least 7 years’ experience in regulatory affairs in medical device industry and previous management experience or equivalent
• Experience with communication to health authorities (e.g., FDA, Health Canada)
• 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 regulatory submissions for novel devices
• Experience with regulatory submissions for a 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.

Benefits

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.