Sr. Regulatory Affairs Specialist-Medical Device

BioPhase Solutions specializes in recruiting talented professionals for San Diego's Scientific and Clinical Research community. We currently have an opening for a Sr. Regulatory Affairs Specialist-Medical Device.


Responsibilities:
JOB SUMMARY


Develops regulatory strategy. Develops and maintains domestic submissions. Assists in the development and maintenance of international regulatory submissions. Reviews international and domestic labeling, website communications, clinical documentation and contracts ensuring compliance with regulatory requirements. Reviews Corrective Action Request forms for completeness and accuracy before they are entered in the database. Participates in corporate assessments. Coordinates recall activities. Provides regulatory guidance.

 

DUTIES & RESPONSIBILITIESDevelops regulatory strategy and develops and maintains domestic submissions. Assists in the development and maintenance of international regulatory submissions. Participates in corporate assessments, to review corporate quality systems and provide feedback on the effectiveness of those systems. Reviews protocols for compliance to the submission strategy. Reviews domestic and international labeling for compliance to labeling requirements, including content, format, 510(k) impact, etc. Provides regulatory/labeling support for International CE product marking and regulatory submissions. Reviews medical/scientific literature to support 510(k), labeling, and clinical strategy. Reviews Corrective Action Request forms for completeness and accuracy, publishes reports and follows up on issues. Coordinates recall activities. Develops and maintains tracking information for product recalls. SAP system resource for regulatory events such as recalls, labeling, etc. Responsible lead for Device Listings and Facility Registrations (State & Federal), and official correspondent with the FDA. Responsible Regulatory lead for Review & Approval of Post Release NCMR's. Review & approve risk assessments as back-up to Director of Regulatory Compliance. Responsible regulatory lead for contract review. Provides regulatory information for Quarterly Finance Report.



Qualifications and Requirements:Bachelors degree and minimum of 3-5 years related professional experience; equivalent combination of education and experience.Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications. Good prioritizing, organization, interpersonal, communication and analytical skills. Knowledge of instruments and disposable design practices. Knowledge of ISO 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 roy@biophaseinc.com

Please visit our website to view all our current openings.


www.biophaseinc.com