The Mid-Level FDA Regulatory Associate will be part of the Legal team, and will support the VP, Lead Regulatory Counsel, who is broadly responsible for providing the business with strategic advice and counsel on regulatory issues. The Associate will also support the Global Regulatory Affairs function with US FDA regulatory expertise in support of obtaining and maintaining clinical and commercial regulatory approvals in alignment with business objectives. The Associate will work closely with the Global Regulatory Affairs function, providing guidance and expertise in support of US regulatory product submissions. In addition, the Associate will play an important role in developing regulatory infrastructure and documentation templates to support regulatory processes.
This is a full-time, exempt field-based position, reporting to the Vice President, Lead Regulatory Counsel.
Essential Duties and Responsibilities:
- Be an integral member of the Lead Regulatory Counsel's team, which is broadly responsible for providing the business with strategic advice and counsel on regulatory issues and providing the Global Regulatory Affairs function with US FDA regulatory expertise in support of obtaining and maintaining regulatory approvals.
- Under the direction of the Lead Regulatory Counsel, liaise with other business functions as needed (Clinical, Medical Affairs, Quality Assurance, Clinical Operations, Marketing) to provide regulatory affairs and regulatory sciences guidance throughout the product development cycle.
- Hands on drafting and review of US FDA filings for the company's commercial devices and investigational devices under clinical study, including pre-submissions and postmarket approval reports.
- Provide regulatory-based scientific and statistical input in the planning and design of clinical studies (including feasibility studies), premarket clinical studies and postmarket studies in support of US FDA marketing applications.
- Help facilitate cross-functional team inputs for regulatory submissions.
- Support the Lead Regulatory Counsel in the assessment of regulatory pathways for new products and product modifications.
- Remain current on regulatory issues/trends affecting the business, assessing and communicating their impact to colleagues, product development/support teams, and to others in the business.
- Under the direction of the Lead Regulatory Counsel, assist in the creation or updating of regulatory standard operating procedures, work instructions, and policies to ensure compliance with regulatory and clinical study-related activities
- Advanced degree in life sciences, health technology, law or engineering (MS, MPH, JD, etc.)
- Biostatistics proficiency, including use of statistical programs, a plus
- Seven (7) years of experience in the Life Sciences industry
- Minimum of five (5) years of directly-related professional experience (US Regulatory) in the medical device field, in increasingly responsible positions
- Substantial experience with the regulation of class III medical devices in the US
- Extensive knowledge of US medical device regulations, 21 CFR Part 812 governing investigational devices, related standards, FDA guidance documents and Good Clinical Practice standards
- Demonstrated success in the preparation and submission to FDA of premarket and postmarket regulatory submissions (PMAs, HDEs, IDEs, annual reports), including pre-submissions.
- Experience working and communicating with the US FDA's Center for Devices and Radiological Health (CDRH)
- Demonstrated cross-functional collaboration and teamwork skills
- Demonstrated ability to understand advanced technical/scientific principles that relate to complex products and processes
- Demonstrated ability to provide technical review of data or reports that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
- Superb attention to detail and excellent communication skills
- Collaborative and independent working style
- Ability to organize, plan and adjust work assignments while meeting deadlines
- Eager to learn and learn quickly
- Excellent English (written and spoken); other European languages an advantage
- Office software proficiency
- Fluent in English and preferably German, both written and spoken; any further languages are of benefit
Ability to lift up to 20 pounds
Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
As part of our commitment to health and safety COVID-19 vaccines are required for our current U.S. employees. As an Equal Opportunity Employer and it is our policy to provide reasonable accommodations to any qualified individual who because of a medical condition or sincerely held religious belief or practice receives an exemption from the vaccination requirement, provided that such accommodation would not result in an undue hardship for the company. For more information regarding the Novocure's COVID vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition team.