The Senior Regulatory Specialist will be a key member of the PaxMed International team, responsible for development of regulatory submissions for our clients, who are medical device companies. 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 managing the project to ensure efficient and timely completion.
The position requires an individual who has excellent leadership, organizational, written and oral communication skills. The individual must be highly self-motivated and able to work effectively with minimum supervision. As well, the successful candidate will demonstrate 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), IDE and PMA processes, as well as Canadian and European regulations, including Medical Device Licence applications, EU Technical Files and Design Dossiers. Working knowledge of other international regulatory requirements is a plus. Multi-lingual fluency is desirable, as the PaxMed International client base is worldwide.
This is a salaried position with flexible hours and may be a fully in-office position in northern San Diego, or may be a hybrid position, with a portion of the work done remotely.