Would you like to be part of a dynamic and exciting team delivering high level support that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our growing team and use your exceptional technical and organizational skills to help us deliver on our mission of democratizing Data-Driven Medicine. Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.

In our journey to impact on patients’ lives, we are looking for a Regulatory Affairs Director who reports directly to the VP of Regulatory Affairs & Quality Assurance.

As Regulatory Affairs Director, you plan, direct, or coordinate regulatory activities linked to business activities to ensure compliance with applicable regulations. You provide responses to regulatory agencies regarding product information or issues. You also develop strategies to ensure regulation compliance and make sure that necessary documentation is completed and submitted. You manage a team who contribute to the Regulatory Department’s goals and missions.

Your key responsibilities would be (but not limited to):

• Develop, implement and execute regulatory strategies for selected products and lead product registration/submission for IVDs/Companion Diagnostics/SaMD in international markets.
• Outline requirements to meet regulatory requirements.
• Collect, collate and evaluate scientific data from a range of sources, for technical documentation and product registration.
• Supervise the review of labeling and promotional materials, and Safety Data Sheets
• Ensure the implementation of appropriate Regulatory Processes including Post Market Surveillance activities
• Liaise and negotiate with regulatory agencies, and/or third parties for submission and product registration
• Provide regulatory guidance and expertise to all staff members, and train staff on regulatory processes.
• Translate regulations into actionable processes and requirements
• Perform regulatory watch to identify upcoming modifications or trends in regulation/standadrs to anticipate changes needed to ensure that products and processes comply with the legislations of appropriate markets
• Develop remediation plans as needed to align with new regulations
• Coach, manage, supervise RA assistant(s), associate(s) and manager(s) on a daily basis.

Requirements

• 7+ years of relevant experience, in regulatory affairs for medical device or In-Vitro Diagnostic company.
• Self-driven can-do attitude with ability to move from details to big-picture thinking and deliver results in a timely manner.
• Ability to work under time pressure and in a changing environment and to use own judgment and initiative in problem resolution.
• Strong organizational and project management skills.
• Strong interpersonal skills and the ability to develop trusting and sustained relationships across geographic distance and diverse cultures and to interact and communicate at all levels of the organization.
• Fluency in English is a must

Benefits

• Career opportunities in a fast-growing company with worldwide reputation
• A flexible and friendly working environment with a collaborative atmosphere
• Fantastic office locations in the USA.
• An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
• A fast-growing company with plenty of opportunity for personal growth and development

Start: ASAP (or as agreed)

Contract type: permanent full-time

Application process

If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.

After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.