Principal Regulatory Specialist

POSITION SUMMARY:

This position will be responsible for global regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical devices in targeted global markets. 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 require direct and hands on experience to support the development and implementation of FDA QSR, EU MDR (EU 2017/745) and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

EDUCATION and EXPERIENCE: