Job ID 535
Experience 8 Years +
Industry Medical Device
Director Regulatory Affairs, and Clinical Affairs
Location: San Francisco / Remote
Reporting to the CEO, the Director of RA/CA will provide Regulatory and Clinical expertise in support of the Company’s business activities as well as new and to be marketed products.
- Oversee the execution of US and International Regulatory strategies for earliest possible approvals of Regulatory applications at all stages of development.
- Provide Regulatory expertise and guidance to Project Teams on steps necessary to comply with US FDA and international country legislation, regulations and guidance documents.
- Oversee direction, planning, execution and interpretation of clinical trials/research and data collection activities.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
- Responsible for directing human clinical trials, if required, phases I–IV, for company products under development. (clinical trials are underway at present and new studies are currently being planned).
- Oversee the Clinical and Regulatory departments in planning, execution and management of clinical trials protocol, compliance, contracting and Regulatory submissions & adherence to standard operating procedures to ensure timely submissions.
- Leadership Responsibilities
Experience with medical devices (preferably Class II and Class III devices) and strong working knowledge of US FDA guidance, EU Medical Device Directive (MDR/MDDEV) and ISO guidance documents, Canadian Medical Devices Conformity Assessment (CMDCAS).
Confidence and familiarity of Quality requirements, processes and Quality systems, including DHF, product design and manufacturing.
Strong working knowledge of US and international Regulatory requirements for human factors design, use labelling, and warning and precaution labelling
BS or BA degree with 10 years of experience or an MA degree with 7 years experience