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Posted: Friday, August 4, 2017 5:40 AM

Job Description:/h3:
Job Title Sr. Regulatory Affairs Specialist

Valencia, CA

Working with minimal supervision, manage complex projects/products, including responsibility for the content, assembly, pre:final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues.

BA/BS or MS degree in Life Sciences, Engineering, or health care:related discipline.

Five or more years of experience in the medical device industry, preferably in a small manufacturing/R and D environment that includes medical writing, clinical studies, regulatory submissions, and regulatory reviews.

* Must have experience developing, writing, and organizing all aspects of the IDE/PMA/510(k)s and CE Submissions.
* Ability to independently analyze and interpret novel clinical, medical and scientific data.
* Current knowledge of current U.S. FDA and global (Canada, Australia, European Union, Latin America, India, China, etc.) regulatory requirements within the medical device industry. Excellent organizational skills and attention to detail.
* Strong analytical, management, communication and interpersonal skills. Good knowledge of MS Office, Internet, databases, etc.
* Ability to work with minimal supervision in a busy environment.
* Excellent writing skills and the ability to write scientific summaries.
* Must be able to handle multiple assignments and perform in a diverse cross:functional team environment.

Company Description:/h3:
Market leader in Orange County in Staffing, Recruiting and payroll servicing.


• Location: San Fernando Valley, valencia

• Post ID: 132941843 sanfernandovalley is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017