Senior Regulatory Project Manager

ClinForce is currently seeking a Senior Regulatory Project Manager in Plainsboro, NJ.
Successful candidate will identify, review and anticipate emerging regulatory issues likely to impact the company. Develop and implement regulatory strategies and guidance based on U.S. and International requirements as defined in FDA regulations, ISO 9001 Standards, ISO 13485:2003 Standard, Medical Device Directives (93-42EEC), Canadian Medical Device Regulations and other International Regulations. Establish effective dialogue with U.s> and International regulatory authorities. Directs the planning and preparation of U.s> and International regulatory submissions for products. Facilitate timely product registrations and regulatory approvals. Other responsibilities include:
Obtains/generates information to be submitted to regulatory authorities and prepares required regulatory submissions
Acts as liaison with appropriate local, national and international regulatory authorities
Provides regulatory guidance to clinical affairs, design control, manufacturing and production development groups
Review changes in manufacturing facilities, manufacturing procedures and analytical methods
Represent regulatory on project planning and review meetings, participates in the final company document review and corrections
Identifies and ensures the establishment and monitoring schedules for submission documentation, review, protocols and reports received; prepares additional written materials as needed
Coordinates and prepares 510k Premarket Notifications, IDEs, PMAs, INDs, NDAs, Design Dossiers and Technical Files
Prepares responses to FDA letters, supplements and amendments; participates in FDA inspections and presentations
Writes departmental SOPs as needed
Provide input for preparation of the department's budget; ensures that the department operations within capital and expense budget guidelines
Assists as necessary in supporting the handling of product complaints for MDR, Vigilance, Canadian Medical Device reporting requirements and preparation of Health Hazard Evaluations as required
Assist with ongoing training in Quality System Regulation, ISO Standards and other International Regulations
Performs all other related duties as directed by supervisor and management
REQUIREMENTS
Must have proven ability to prepare and submit documents to FDA, such as 510k Premarket Notifications, Investigational Device Exemptions (IDEs), Premarket Approval Applications (PMAs), Investigational New Drug (IND) or New Drug Applications (NDA)
Must possess and demonstrate and excellent understanding of FDA, International ISO Standards, Medical Device Directives and other International Regulation regulatory requirements
Must have experience interfacing with FDA
Must have strong writing, project management and communication skills
Master's degree in science or other technically related field with 5 years experience or a Bachelor's degree in science or other technically related field with 5 - 10 years of experience, and/or equivalent combination of education and experience in preparing regulatory submissions for device and/or