RefleXion Medical, a medical technology company in Hayward, CA, seeks a Senior Regulatory Affairs Specialist to plan, direct, and coordinate the scientific, regulatory, and business issues of the company’s patented technology to ensure national and international regulatory requirements are met. The applicant will identify information needed for regulatory compliance, obtain data, and ensure that the information is effectively presented for the registration of products worldwide.
Minimum requirements (Must be evident on the resumé):
Bachelor’s degree in a scientific discipline (engineering, biomedical, medicine, pharmacy, physics, biology)
Current Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS)
5 years experience in medical device regulatory affairs for devices that are electromechanical or complex software-driven medical devices. Experience cannot be exclusively IVD devices.
The 5 years experience must include:
Project management experience in the development, writing and submittal of successful 510(k)/PMA/De Novo U.S. submissions
At least 1 submission for each of : US 510(k); Health Canada Medical Device License application; and CE Mark application/ technical file
Working knowledge of ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971 as evidenced by coursework or at least 1 submission that required use of each standard
Knowledge of software development as it relates to regulatory submissions as evidenced by at least 1 submission that included software subject to IEC 62304
Experience working on post market activities such as establishment licenses and registrations
Leading regulatory review of complaints for MDR reporting decisions and submitting reports to FDA