Regulatory Affairs Manager

POSITION SUMMARY:

This position will be responsible for all regulatory activities related to the development and implementation of both US (FDA) and OUS global regulatory strategies to support the submission, filing, and registration of multiple indications in Dermatology and Oncology medical device development assets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. In addition, this position will support the development and implementation of FDA QSR and ISO 13485: 2016 QMS, EU MDR regulatory requirements, and applicable international regulatory compliance activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

COMPANY OVERVIEW:

Pulse Biosciences, Inc. is a clinical-stage medical device company using a novel and proprietary platform technology called Nano-Pulse Stimulation or NPS. NPS can be tuned to induce a variety of cellular responses including secretion, apoptosis and necrosis by modulating the NPS pulse parameters, making it applicable to a wide variety of cell types and therapeutic applications. One of the more promising applications of NPS is the treatment of solid tumors, where pre-clinical data has shown that NPS provides effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death (ICD).

CONTACT:

Submit resumes to: careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.