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 5,000 liver transplant operations globally.

Position Summary

The Regulatory Affairs Medical Writer supports regulatory submissions and clinical documentation by generating and maintaining regulatory deliverables that incorporate clinical data, scientific literature, and regulatory rationale. This role reports directly to the Regulatory Affairs Manager and collaborates with Clinical Affairs and other cross-functional teams.

The successful candidate will contribute to the preparation of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and documentation in support of IDE applications and regulatory submissions to Notified Bodies, the FDA, and other global agencies. This role requires a strong foundation in scientific research, medical writing, and familiarity with regulatory requirements including EU MDR and FDA regulations.

This is an onsite position in Madison, NJ and will require periodic travel to the UK and other locations.

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 exhaustive.

Major Responsibilities

Under direction from the Regulatory Affairs Manager, the Regulatory Affairs Medical Writer will be responsible for:

Regulatory Medical Writing Support

· Perform literature searches, literature reviews, and clinical data reviews to support development of clinical documentation (CERs, CEPs) and other regulatory documentation.

· Participate in initiatives to improve medical writing processes and standards.

· Assist in drafting and maintaining clinical sections of regulatory submissions, including support for Investigational Device Exemption (IDE) applications and pre-submissions.

· Contribute to regulatory justifications, benefit-risk analyses, and responses to regulatory queries.

· Assist in the clinical review of technical documents and reports in alignment with EU MDR, FDA, and other applicable regulations.

· Evaluate the risk of proposed regulatory strategies in context of sufficient clinical data.

General Regulatory Support

· Work with cross-functional teams to compile documentation for regulatory submissions and audits.

· Maintain records and manage regulatory information using Rimsys, QMS platforms, or other internal tools that support quality and regulatory documentation workflows.

· Liaise with Quality, Clinical, Product Development, and other Regulatory team members to gather technical and clinical data.

· Prepare internal updates and reports on document status and clinical findings.

· Provide updates and recommend changes to company processes or documentation due to changes in regulations, published guidance documents, and/or standards.

Requirements

Skills & Experience

· Experience in regulatory affairs or clinical writing

· Excellent scientific and technical research and writing skills

· Strong attention to detail and documentation quality

· Strong ability to communicate effectively across cross-functional teams

· Proficiency in Microsoft Office 365

· Ability to understand, interpret, and summarize scientific or medical data

· Knowledge of regulatory frameworks

· Ability to manage multiple priorities while effectively managing time

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

Qualifications

· Bachelor’s degree in a scientific or technical discipline

· 5+ years of experience in regulatory affairs or clinical writing, preferably in a medical device setting.

· Required experience with regulatory frameworks, including EU MDR, 21 CFR, and ISO 13485

· Willingness and ability to travel occasionally (up to 5% annually), typically for meetings, training, or audits.

· Experience supporting clinical documentation for regulatory submissions (e.g., IDEs, CERs)

#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 $145,000 - $155,000 annually, with a 10% target annual bonus and benefits.

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.

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