Regulatory Affairs Specialist

OrganOx; Alabama; Hybrid; USD 100,000 - 150,000; Full time

Job summary

OrganOx is seeking a Regulatory Affairs Specialist to prepare regulatory submissions for North America and support GMP/ISO compliance. The role is remote with in-person collaboration and will report to the VP of Regulatory Affairs and Quality, North America, working with teams in the UK.

The ideal candidate has at least 3 years’ regulatory submission experience for Class II/III medical devices, strong FDA knowledge, and excellent writing skills.

Qualifications

• BS degree in engineering, life science, or related field.
• At least 3 years' regulatory submission experience for Class II/III medical devices.
• Strong knowledge of FDA processes for medical device compliance.
• Ability to write clear regulatory strategies and submissions.
• Understanding GMP compliance in Quality Control.
• Experience collaborating with Manufacturing, Quality, R&D, Clinical and Marketing.
• Proficient in MS Office; excellent verbal and technical writing skills.
• Ability to work independently.

Responsibilities

• Prepare regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements) for FDA and Health Canada.
• Interface with FDA and Health Canada on assigned projects.
• Respond to FDA and Health Canada requests for additional information.
• Interact with FDA, Health Canada and/or Notified Body during quality inspections; respond to reports during inspections.
• Keep up with changes to US/Canada regulatory requirements and International Standards related to OrganOx products.
• Communicate regulatory initiatives or changes in medical device law to personnel, customers, subcontractors, regulators, and third parties.
• Review regulatory guidances for assigned projects to ensure compliance and determine required submissions.
• Prepare visualizations and conclusions for presentation to upper management.
• Work with key stakeholders on Regulatory and Quality topics.
• This role requires work at the Giralda office in Madison NJ ~2 days/week; some US/UK travel.

Skills

Regulatory submissions

Regulatory strategies

FDA processes

GMP compliance

Cross-functional collaboration

MS Office

Technical writing

Independent work

Education

BS degree in engineering or life science

Tools

MS Office

Job description

ABOUT ORGANOX:

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). Its 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 position of Regulatory Affairs Specialist is responsible for preparing regulatory submissions (IDEs and PMAs) for North America as well as assisting in the implementation of the company’s quality goals and objectives. This position will be remote.

Other responsibilities include assisting with compliance activities related to GMP and ISO regulations and associated standards, as well as, assist in the performance of internal quality and regulatory compliance audits.

This role will report directly to the VP of Regulatory Affairs and Quality, North America and will also work closely with the Regulatory Affairs Manager located in the UK.

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 VP of Regulatory Affairs and Quality, North America.

Major Responsibilities

Under direction from the Director, Regulatory Affairs, the Sr. Regulatory Affairs Specialist will be responsible for:

• 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


• Interacting with FDA, Health Canada and/or Notified Body during quality inspections. Responsible for responding to requests for special reports during inspections


• 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


• Reviewing regulatory guidances for assigned projects to ensure compliance with regulations and determining whether regulatory submissions are required


• Prepare visualizations and conclusions for presentation to upper management


• Working with key stakeholders in relation to Regulatory and Quality topic


• This role will require that you work at the Giralda office in Madison NJ for approximately 2 days per week, subject to your manager’s direction. This role will require some travel within the US and at times to the UK.

Qualifications

• Working knowledge of FDA processes for medical device compliance


• 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


• A BS degree in an engineering, life science, or related area


• At least 3 years' regulatory submission experience for Class II/III medical devices

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.

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.