Preferred location Cambridge, MA or Hartland, WI
As Regulatory Affairs Specialist and member of the Watson Health Compliance Organization you will support the Quality Management System and provide regulatory support for development programs of new and existing products.
Essential Job Duties
· Under supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
· Supports FDA, notified body, and other regulatory inspections
· Provides business impact analysis of trends in international regulatory developments and proposes course of action to Watson Health Compliance managers
· Evaluates proposed products for regulatory compliance requirements internationally
· Initiates product holds as needed where market authorizations have not been achieved.
· Develops and implements regulatory strategies for new and modified medical devices for global markets as determined by the Offering Management teams. Ensure strategy is based on current local registration requirements and applicable industry standards.
· Support interactions with global government agencies (such as FDA, CMDE, JFDA, etc.) regarding regulatory submission strategy and approval reviews.
· Coordinate complex logistical details including resource and project timeline planning, liaison with functional group representatives and identification/coordination of source documentation.
· Under direction, review change control documents and ascertain regulatory impact.
· Coordinate submission issues to ensure compliance and quick and complete resolution.
· Responsible for products post-market compliance globally such as AE-reporting, recall and conduct local CER.
· Determine applicable compliance requirements for new products and changes to existing products licensed worldwide
· Assists with the development of regulatory department policy and procedure implementation.
· Reviews device labeling and promotional materials for compliance with global submissions and applicable regulations; analyzes appropriate changes.
· Reviews advertising and promotional material to the proper global agencies for approval as needed
· Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures
· Assists with activities related to the corrective and preventative action (CAPA) process
Required Technical and Professional Expertise
· Minimum of 3-5 years in the medical industry in Regulatory Affairs
· Experience with Medical Software local testing based on National as well as Industrial standards and has a good relationship with local testing house.
· Experience with Medical Software local Clinical Trial and has a good relationship with major CROs or Hospital Associations.
· Experience with drafting Technical standards on Medical software.
· Proficient knowledge of global regulatory submission requirements for medical devices
· General understanding of product development process and design control
Preferred Tech and Prof Experience
· Must be well versed in the medical device quality system regulations and international regulatory requirements for medical devices
· Specific experience with software medical devices desired.
· Excellent communication and interpersonal skills are essential.
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.