Senior Regulatory Affairs Specialist - Software

OrganOx Limited; Madison (NJ); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health, dental, vision, disability

401(k) with company match

Paid time off and wellness facilities

Employee discounts

Job summary

OrganOx Limited is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for North America, including FDA activities for SaMD/SiMD and electromechanical devices. The role requires collaborating with Manufacturing, Quality, R&D, and Marketing to ensure compliance with ISO, GMP, and medical device standards.

The position offers flexible remote or hybrid on-site work in Madison, NJ with travel up to 5% domestically or internationally, and reports to the Director of

Qualifications

• Experience with FDA regulatory pathways for medical devices (510(k)/PMA).
• Experience with SaMD/SiMD, cybersecurity, and electromechanical devices.
• Familiarity with Class II/III regulatory requirements and quality systems.
• Ability to craft regulatory strategies and submissions and communicate with agencies.

Responsibilities

• Prepare regulatory submissions (FDA/Health Canada) and maintain submission calendars.
• Support pre- and post-market regulatory activities and lifecycle changes.
• Collaborate with Manufacturing, Quality, R&D, Clinical and Marketing teams.
• Interface with FDA and Health Canada; respond to information requests.
• Monitor changes to US/Canada regulations and international standards.

Skills

FDA processes

SaMD/SiMD/Cybersecurity

Class II/III devices

Regulatory submissions

GMP knowledge

Cross-functional

MS Office

Communication

Independent work

Education

Bachelor’s degree in engineering or life sciences

RAC (optional)

Job description

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 7,000 liver transplant operations globally. OrganOx was also recently acquired by Terumo corporation (TSE:4543). Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. Q-Submissions, 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, Regulatory Affairs, Software and Innovation 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 Remote or hybrid on-siteposition in Madison, NJ and may require up to 5% travel domestically or internationally.

Major Responsibilities

Under direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for:

• Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence.
• 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.

Skills and Experience

• Working knowledge of FDA processes for medical device compliance.
• Experience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Cybersecurity and Electromechanically products are required.
• 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 areas.
• Minimum 3-8 years of related regulatory experience (depending on education) with Class II/III medical devices and Software products.
• Regulatory Affairs Certification (RAC) (Optional)
• Ability to travel 5% of the time domestically or internationally.

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.