Slone Partners is seeking a Regulatory Affairs Director, with a well established yet continuously growing laboratory client. Our client is focused on next generation preventative diagnostics and this person will be an essential member of the senior leadership team reporting directly to the Chief Operating Officer. This role is based in the greater San Francisco Bay area and our client offers a competitive compensation/benefits package.
Please note: An extensive regulatory background in the In-vitro Diagnostic (IVD) space is required. Key qualifications include:
In-depth understanding and experience with FDA, CE and ISO regulatory requirements relative to developing strategic regulatory development plans.
Experienced RA leader to core team(s) for product realization diagnostic projects
Develops regulatory strategies and implementation plans, in partnership with the project teams that achieve the Company’s strategic goals
Prepares and submits files for global regulatory clearances and approvals.
Provide regulatory leadership and direction for currently marketed products and new product launches
Manage submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
If you meet these qualifications and wish to be considered for this position, please click on the “Apply” and submit your resume.
Slone Partners is a premier executive search firm that specializes in recruitment for the diagnostics, life sciences, clinical trials, contract research, healthcare information technology, and laboratory testing industries.
Since 2000, Slone Partners has been chosen by innovative, world-class organizations to fill key positions with the best industry talent. Our extensive database of industry ...professionals, along with the knowledge of our executive recruiters, makes the presentation of the best candidates a Slone Partners standard.
AREAS OF EXPERTISE:
Clinical Trials / CRO
Diagnostics / In-Vitro Diagnostics
Healthcare Information Technology
Laboratory Testing Services
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Contact us today toll free at 1 877 416-0681 to discuss your hiring strategy and have access to the best talent to join your organization.
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