Senior Regulatory Affairs Specialist

OrganOx•Madison, NJ

4d•Hybrid

About The Position

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) 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 Senior Regulatory Affairs Specialist is responsible for leading and supporting regulatory activities for assigned devices and projects throughout the product lifecycle. This role develops regulatory strategies, performs regulatory assessments for product and process changes, and prepares submissions and other regulatory deliverables for the US and applicable international markets. 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. This is a hybrid position in Madison, NJ, and may require up to 5% travel to OrganOx and/or supplier locations.

Requirements

Strong experience in regulatory affairs within the medical device industry, including experience with U.S. Class III devices.
Working knowledge of regulatory requirements outside the U.S., including Canada, Europe, United Kingdom, and other regulatory jurisdictions.
Experience evaluating proposed product changes and determining appropriate regulatory actions.
Experience evaluating standards (ISO, ASTM, etc.) and guidance documents for applicability and compliance requirements.
Excellent verbal communication and technical writing skills.
Ability to manage multiple priorities and work independently while escalating issues appropriately.
Experience in cross-functional collaboration with Manufacturing, Quality, R&D, Operations, and Clinical.
Experience engaging with regulatory authorities to support submissions, respond to inquiries, and facilitate successful interactions throughout product lifecycle.
Minimum of a Bachelor’s degree in technical discipline (Engineering or Life Sciences), or other related area of study.
Minimum of 5 years of regulatory affairs experience within the medical device or similar industry.
Demonstrated experience with successful submissions in key markets such as U.S. and EU.
Ability to travel 5% domestically and/or internationally.

Responsibilities

Leading and supporting pre-/post-market regulatory activities for assigned devices, projects, and product changes.
Performing regulatory impact assessments for design, labelling, packaging, supplier, and manufacturing changes to determine appropriate regulatory pathways and submission requirements.
Preparing, compiling, and coordinating regulatory submissions and change notifications, including PMAs, PMA supplements, amendments, annual reports, and other change notifications or submissions.
Supporting regulatory authority interactions by drafting correspondence, coordinating response strategies, tracking submission progress, and preparing responses to requests for additional information.
Partnering with project teams to define regulatory requirements, review supporting documentation, and help ensure development and change activities are aligned with applicable regulatory expectations.
Reviewing documentation and evidence that may support regulatory activities, including verification and validation documentation, risk management documentation, and change records.
Contributing to departmental process improvements, regulatory intelligence activities, and internal tools or procedures that improve consistency, compliance, and efficiency.
Providing training and support to other members of the department.
Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies