Sr. Regulatory Affairs Specialist
BioPhase Solutions Inc - San Diego, CA

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BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We currently have a direct hire opening for a Sr. Regulatory Affairs Specialist for a leading Medical Device company in San Diego.
Sr. Regulatory Affairs Specialist


Responsibilities/ Job Functions:
Assist and participate in the development of regulatory strategies
Participate in internal audits
Create, approve and review labeling for packaging, promotional and educational materials.
Request documentation and updates for the creation / maintenance of regulatory filings
Reviews domestic and international labeling for compliance to labeling requirements, including content, format, 510(k) impact, etc.
Provides regulatory review and approval for domestic and International product marketing communications.
Responsible for regulatory review & approval of non-conforming product.
Provides regulatory guidance as needed.
Experience with sterile disposable products. Familiar with product biocompatibility, sterilization and packaging requirements.

Bachelor’s degree and minimum of 3-5 years related professional experience; preferred
Medical device 510k/global experience including electro-mechanical/software and/or single-use disposables.
Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications.
Good prioritizing, organization, interpersonal, communication and analytical skills.
Knowledge of software, instrument and disposable design practices.
Knowledge of ISO / MDD and Canadian regulatory requirements.
Ability to influence and work with personnel at all levels and functional boundaries. Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.)

BioPhase Solutions – the right opportunities with the right companies

Our goal is to make a positive impact to science by matching candidate's skill sets with company's needs. Our staff has a reputation for excellence in the industry by developing professional relationships with San Diego’s finest pharmaceutical and biotechnology companies. For immediate response please forward your resume to
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