Regulatory Affairs Specialist

OrganOx is a commercial-stage organ technology company developing solutions to improve outcomes for patients with acute or chronic organ failure. The Regulatory Affairs Specialist supports global regulatory submissions, registrations, product lifecycle activities, regulatory information management, and cross-functional coordination for OrganOx medical device products.

Responsibilities

Support the preparation, compilation, review, and submission of regulatory filings for OrganOx products in the United States, European Union, Canada, Australia, and other markets

Work collaboratively across the Regulatory Affairs function, including software, retained unit, disposable set, labelling, and regulatory systems, to coordinate regulatory deliverables and maintain alignment across product areas

Support regulatory authority and Notified Body interactions associated with assigned submissions and regulatory activities

Create, maintain, and periodically reconcile regulatory records to ensure accurate representation of product registrations, submissions, approvals, certificates, licenses, regulatory commitments, market status, and other regulatory information

Support configuration, process improvements, reporting, and implementation of new functionality within Rimsys

Maintain alignment between regulatory records, change-control activities, approved product configurations, and other applicable business systems

Support maintenance of regulatory registrations, renewals, annual reports, and other recurring regulatory obligations

Collaborate with Regulatory Affairs and cross-functional stakeholders to support assigned regulatory activities and ensure regulatory requirements and deliverables are appropriately communicated and completed

Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Benefits

Hybrid work arrangement in Madison, NJ, with approximately 2 days per week in the office

Health coverage available from day one

Dental coverage available from day one

Vision coverage available from day one

Disability coverage available from day one

Flexible spending accounts available from day one

401(k) retirement plan with company matching after 90 days

Paid time off

Paid holidays

Additional leave benefits

Employee discounts

Access to an onsite wellness facility

Opportunities for ongoing professional development

Company

Transportable automated liver perfusion devices for transplantation

Oxford, Oxfordshire, GBR

http://www.organox.com/

Founded in 2008

51-200 employees

Qualifications

Working knowledge of medical device regulatory requirements and FDA regulatory processes

Ability to prepare clear and well-organized regulatory documentation and submissions

Working knowledge of medical device regulatory requirements in one or more international markets such as the European Union, Canada, and Australia

Experience with regulatory information management systems or similar data systems; Rimsys experience preferred

Experience collaborating cross-functionally with Manufacturing, Quality, R&D, Clinical, Marketing, and other business functions

Strong organizational skills and attention to detail, with an ability to manage multiple priorities

Excellent verbal communication and technical writing skills

Minimum of a Bachelor's degree in technical discipline (Engineering or Life Sciences), or other related area of study

Minimum of 3 years of regulatory affairs experience within the medical device or similar industry

Ability to travel 5% domestically and/or internationally

Required skills

Medical device regulatory requirements, FDA regulatory processes, Regulatory documentation and submissions, International medical device regulations, Regulatory information management systems, Rimsys

Experience

3+ years