Provides execution and support of the regulatory compliance function for all products and processes in the Medical Division to achieve regulatory compliance objectives. Responsible and accountable for regulatory compliance activities for product lines in both domestic and international markets. Assists with management and maintenance of quality system processes to ensure compliance with FDA QSR and ISO 13485 regulations. Determine and define regulatory compliance requirements to individuals and project teams throughout the company. Collaborate with cross-functional teams to facilitate achievement of business objectives while ensuring compliant operation within the flexibility of the regulations. Work closely with management and corporate regulatory compliance to ensure alignment with Cantel business objectives and regulatory compliance direction.
Provides execution and support of the regulatory compliance function for all products and processes in the Medical Division to achieve regulatory compliance objectives.
Develop and implement regulatory strategy for assigned projects
Assist with preparation, coordination, and management of regulatory inspections in accordance with applicable regulations
Assists with management and maintenance of quality system processes in collaboration with cross-functional teams
Work closely with corporate regulatory compliance to ensure alignment with Cantel business objectives and regulatory compliance direction.
Review and communicate emerging regulatory requirements to cross-functional teams to ensure compliance
Ensure Quality Management System remains consistent with SOP development and implementation
Collaborate with cross-functional teams to facilitate achievement of business objectives while ensuring compliant operation
Maintain up-to-date knowledge of laws, regulations, and policies enforced by the International and Federal governments as they relate to Crosstex products.
Advises cross-functional teams within company of regulatory compliance requirements.
Determines suitability of available product information for submission to Regulatory Agencies in order to meet regulatory requirements.
Responds to government inquiries during and after product registration in order to continue to comply with changing requirements.
Supports and assists with trade compliance activities if needed such as US Customs inspections regarding import and export requirements.
Performs RA document control functions, including document login, tracking, processing, review, distribution and release and archiving of documents.
Coordinates the revision, review, and approval and obsoleting of SOPs and other QSR and ISO13485 documents.
BS degree in scientific, engineering or technical discipline.
2-4 years of experience in regulatory compliance, preferably in medical devices, or equivalent.
Background experience in a medical device industry is required with experience in sterilization or biological/chemical indicators is preferred but not required.
Strong knowledge of U.S. regulations in the areas of the FDA QSR and international regulations such as ISO 13485 and EU MDD 93/42/EEC is required.
Demonstrated independent problem solving skills.
Proof of solid written and verbal communication skills, especially when dealing with governmental agencies.
Experience in quality system compliance, preparation of US and international regulatory submissions is required.
General computer knowledge, experience using search programs such as Access, Excel and Microsoft Word is required.
Crosstex International is a leading global manufacturer of infection control and prevention products for the healthcare market. We create high quality, innovative products, the majority of which are manufactured in the United States. Our broad range of products for multiple healthcare disciplines include: SecureFit® Face Masks, ConFirm® Sterilization Monitoring, SaniTyze™ Waterless Antimicrobial G...el and our Patients Choice ® line of preventive products. With ten manufacturing/distribution facilities around the world – 7 in the United States and 3 internationally – Crosstex services the global healthcare community in an efficient and timely manner.