Regulatory Affairs Operations Specialist

Job Title: Regulatory Affairs Operations Specialist 
Duration: 4+months with possible extension
Location: Andover MA
 
Description of Duties: 
Qualifications
Responsible for: 
 • Managing the FDA establishment registrations and device listings process for all Philips facilities. Providing input to management regarding Philips-wide establishment registration strategy. 
 • Managing the medical device manufacturer/distributor US state licensing process for Philips facilities. 
 • Owning the FDA Certificates to Foreign Government and embassy authentication submission strategy and execution for all Philips businesses. 
 • Owning and maintaining the regulatory deliverables database across all Philips businesses, creating a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals. 
 • Owning and maintaining department procedures related to the above responsibilities 
 • Notarizing regulatory documents. 
 
 Education & Training: 
 • Bachelor’s degree in a related technical or business discipline. 
 • A minimum of 3 years related experience in the medical device industry. 
 • Working knowledge of FDA medical device regulations. Experience with FDA establishment registration, medical device manufacturer/distributor US state licensing, and/or Certificate to Foreign Government applications desirable. 
 
 Competencies: 
 • Familiarity with managing Microsoft SharePoint sites. 
 • Demonstrated ability to effectively interact with employees and managers on all levels. 
 • Goal-oriented and proactive in problem solving. 
 • Strong written and verbal communication skills. 
 • Attention to detail. 
 • Must be able to perform responsibilities with minimal supervision.
 
Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560 
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com

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