SENIOR REGULATORY AFFAIRS SPECIALIST – SAN JOSE, CALIFORNIA
WEBCO HR, Inc. is seeking a Senior Regulatory Affairs Specialist for one of our clients located in San Jose, California.
The Sr. Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions in accordance with EU IVDR and for related activities such as development of new procedures, performance evaluation plan and report and training functional team members on the new requirements. This position requires candidate to collaborate with other functions (R&D, Quality, Operations) and external consultants. Experience in project management is preferred.
· Understand and interpret EU in vitro diagnostic device (IVD) regulatory requirements.
· Draft and prepare product technical files compliant to EU IVDR.
· Coordinate and project manage the preparation of technical files by external consultants.
· Represent RA in IVDR core team and identify regulatory activities for project schedule.
· Interface with Notified body to obtain approval of Technical Files.
· Coordinate the preparation of additional data/information requested by notified body and prepares appropriate responses to all such requests.
· Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI) to support the implementation of IVDR.
· Conduct training on IVDR requirements, new SOP’s and WI’s.
· Participate in the development and review of performance evaluation plan and report.
· Review analytical protocols and clinical protocols to assure collection of appropriate data for regulatory submissions.
· Review labels, labeling, and promotional materials for compliance with IVDR.
· Provide regulatory opinions on EU IVDR regulatory requirements, export, and labeling requirements.
· Minimum of a Bachelor's Degree in life sciences or engineering.
· Minimum of 5 years’ experience in regulatory affairs supporting device/diagnostic industry (IVDR/MDR).
· Minimum of 3 years' experience authoring Tech files and interfacing with Notified Bodies to obtain approval.
· 510(k) submission experience is strongly preferred.
· Demonstrated ability to project manage regulatory submissions.
· Demonstrated ability to interpret and implement new regulations.
· Working knowledge of EU in vitro diagnostic or medical device regulatory requirements and quality system standards,
· Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
· Ability to prioritize, multi task, and organize work.
· Base Salary
· Full Benefits
Our client is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. They lead in patient and healthcare worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures and support the management of diabetes.
WEBCO HR, Inc. is an Equal Opportunity Employer