The Regulatory Specialist will be a key member of the PaxMed International team, responsible for supporting the development of regulatory submissions for our medical device company clients. The successful candidate will be responsible for the development of the regulatory submissions, assisting with regulatory strategy, interacting with our clients to collect and organize the required information needed for submissions, and supporting a Senior Consultant to ensure efficient and timely completion.

The position requires an individual who has excellent leadership, organizational and written and oral communication skills. The individual must be highly self-motivated, as well as demonstrating proficiency at building consensus when working within a team setting. Overall, the regulatory arena is a time-sensitive, high-profile area of work where considerable client resources are expended in support of the business plan and a successful candidate must be qualified by education, training, and experience to excel in this assignment.

Must be familiar with the laws, regulations, standards and guidance governing the 510(k) process. Working knowledge of international regulatory requirements and multi-lingual fluency are desirable. Experience with submissions to the Division of Dental and ENT Devices in FDA’s Office of Product Evaluation and Quality/CDRH is a plus. This is a salaried position with flexible hours and may be a fully in-office position in San Diego, may be a hybrid position, with a portion of the work done remotely, or may be a fully remote position.