Senior Regulatory Affairs Specialist

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra ® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. INDs, IDEs and PMAs) for North America as well as assisting in the implementation of the company’s quality goals and objectives.

Other responsibilities include assisting with compliance activities related to ISO, GMP and applicable medical device standards .

This role will report directly to the Director of Regulatory Affairs and collaborate with other team members within the regulatory department as needed.

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 Director of Regulatory Affairs.

This is a flexible on-site position in Madison, NJ and may require up to 5% travel domestically or internationally.

Major Responsibilities

Under direction from the Director of Regulatory Affairs, the Senior Regulatory Affairs Specialist will be responsible for:

· Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Combination products and other new venture initiatives.

· Supporting pre-market and post-market regulatory activities for assigned projects.

· Collaborating with cross-functional teams to provide regulatory support.

· Preparing regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada.

· Interfacing with the FDA and Health Canada on assigned projects.

· Responding to FDA and Health Canada requests for additional information.

· Keeping abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes.

· Formally communicating regulatory initiatives or changes in the applicable medical device law with company personnel, customers, subcontractors, regulatory agency representatives, and third-party organizations.

· Perform regulatory change assessments as required.

· Reviewing applicable regulatory guidance and standards for assigned projects to ensure compliance with regulations and determining regulatory impact.

· Prepare visualizations and conclusions for presentation to upper management.

· Working with key stakeholders in relation to Regulatory topics.

· Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Requirements

· Skills and Experience

· Working knowledge of FDA processes for medical device compliance.

· Experience with Software as a Medical Device (SaMD), Cybersecurity and Combination products is preferred.

· Experience with Class II and Class III devices.

· The ability to write clear regulatory strategies and submissions.

· A good understanding of GMP compliance requirements in Quality Control.

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

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

· Excellent verbal and technical writing skills.

· Ability to work independently.

Qualifications

The Senior Regulatory Affairs Specialist will have:

· A minimum of a Bachelor’s degree in engineering, life sciences, or other related area

· A minimum of 3-8 years of related regulatory experience (depending on education level) with Class II/III medical devices

· Regulatory Affairs Certification (RAC) (Optional)

· Ability to travel 5% of the time domestically or internationally.

#LI-Onsite

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

The Pay Range for this position is $115,000 - $140,000 annually, with a 10% target annual bonus and benefits.

At OrganOx, we offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides 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.