SENIOR REGULATORY AFFAIRS Class I & II-SPANISH Bi Lingual 510K Exp #3 (Arcadia)

POSITION: SENIOR REGULATORY AFFAIRS SPECIALIST Spanish Speaking is a MUST****
Reports to: Vice President, Quality Assurance & Regulatory Affairs FLSA Exempt
QUALIFICATIONS:
Bachelor's degree is required, preferably in Regulatory, Engineering, life sciences or other technical area.  RAC certification is a plus.Comprehensive knowledge of FDA and international regulatory requirements governing the manufacturing of Class I and Class ll medical devices.Demonstrated successful track record in preparing and filing 510(k) pre-market notification submissions and international submissions.A minimum of five years experience in Regulatory Affairs in a medical device manufacturer in roles of increased responsibility.Exceptional interpersonal and written and verbal communication skillsDemonstrated ability to work effectively on cross-functional teams.Ability to manage and prioritize multiple projects to meet business objectives.Proficiency in Microsoft Office applications. 
SUMMARY:
The Senior Regulatory Affairs Specialist is responsible for driving the submissions activities of the company and ensuring that all required international and domestic regulatory registrations, clearance and records are complete and in compliance with requirements. The Senior Regulatory Affairs Specialist plays a role in the Company’s Quality System Requirements and must have an overall understanding of the Quality Policy Manual QS?'001.
RESPONSIBILITIES:
Establish, maintain, and monitor regulatory compliance with domestic and international regulatory requirements and standards and communicate changes to the organization.Develop and execute regulatory plans including identifying appropriate device classification and regulatory path of new products for desired markets including US and CE.  Provide Regulatory support to product development activities. Prepare and manage regulatory submissions and associated records at the site, including the assessment of changes to determine regulatory impact.Collaborative with Engineering in the development of CE Technical Files.Work with International partners in obtaining market authorization for our products.Maintain Establishment Registrations, Device Listings and State Licenses.Review and approve advertising and promotional materials and labeling for regulatory compliance.Establish and maintain effective working relationships with the Sales, Marketing, Manufacturing, and Engineering departments and actively participate in cross-functional teams.

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