The Associate Director, Regulator Affairs will be part of the Global Regulatory Affairs team, and be responsible for supporting the team in creating and executing regulatory strategies and objectives in alignment with business needs. This includes the preparation of regulatory submissions required to market new or modified medical devices, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the company’s overall product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. The Associate Director, Regulator Affairs will primarily support the company’s US regulatory activities, but will also coordinate with the global team to ensure compliance with the processes required by the standards and applicable regulations in non-US jurisdictions (Europe, Japan, USA, China and others as needed).

This is a full-time, exempt position that reports to the Vice President, Global Regulatory Affairs and is located in our New York office or our Portsmouth NH office; ability to work remote is a possible option. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Be an integral member of the Global Regulatory Affairs team, which is broadly responsible for obtaining and maintaining regulatory approvals in all relevant markets
• Work closely with the Clinical Operations, Quality Assurance, Supply Chain and Marketing teams, providing regulatory leadership and guidance throughout the product development cycle to establish, promote, improve, educate on, and execute regulatory affairs related processes
• Prepare, or direct the preparation of premarket and postmarket regulatory documents and submissions in the US (and globally, as needed)
• Coordinate cross-functional team inputs for regulatory submissions
• Develop and/or update SOPs related to regulatory processes in the company, in collaboration with other business functions as needed
• Assess regulatory pathways for new products and product modifications
• Develop regulatory strategies and tactical plans for submissions to regulatory authorities
• Identify and communicate potential risks and mitigations associated with regulatory strategies
• Monitor US and worldwide regulatory developments (standards, guidance documents) and communicate emerging opportunities/concerns impacting the company
• Carry out the above tasks with no supervision

QUALIFICATIONS/KNOWLEDGE:

• Substantial experience working and communicating with the US FDA’s Center for Devices and Radiological Health (CDRH)
• Substantial experience with the regulation of class III medical devices in the US
• Demonstrated success in the preparation, submission and negotiation of premarket regulatory submissions (PMAs, HDEs, IDEs) to FDA
• Managerial experience is an advantage
• Demonstrated project management, negotiation, and communication (written and oral) skills.
• Demonstrated cross-functional collaboration and teamwork skills
• Demonstrated ability to resolve problems and make regulatory decisions under pressure
• 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
• Advanced degree in the area of life sciences, health technology, law or engineering
• Minimum of ten (10) years of experience working in the life science industry
• Minimum of five (5) years of directly related professional experience (Regulatory) in increasingly responsible positions in the medical device field

OTHER:

• Ability to lift up to 20 pounds
• Average travel commitment of 10-15%, which includes overnight and international travel as needed
• Fluency in English

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy