Regulatory Affairs Specialist

Responsibilities: Foster close cooperative relationships with all functions in the company relative to regulatory compliance, including working with Product Development, Package Development, Legal, Quality Assurance and Marketing to execute all initiatives for assigned brands. Provide regulatory guidance to product development teams for assigned brands, including claim substantiation, label reviews and advice on regulatory submissions. Maintain and prepare NDA supplements and/or 510(k) applications as well as other regulatory documentation for assigned brands and products. Assist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company's Quality System, external regulatory standards (e.g., ISO 13485), and relevant regulations. Monitor global regulatory developments affecting products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management. Ensure that the activities of assigned industry task forces and committees reflect priorities. Requirements: 6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred. Strong knowledge of OTC drug and device regulations, including labeling requirements Working knowledge of U.S. clinical research and claims support Excellent written and verbal communication skills Demonstrated ability to work with people in an effective and positive manner. Drug or medical device submission and/or maintenance experience The Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing functions. Serve as the regulatory representative on identified product development teams. Create or review U.S. & Canada regulatory submissions that meet company and Develop and implement company and departmental SOPs and provide training/compliance! Propose and meet realistic timelines for regulatory submissions and approvals. Keep up to date on changes in regulatory requirements related to OTC drug, device, and dietary supplement regulations and communicate these changes within the company. Represent company on assigned industry task forces and ensure that company. needs are addressed. Improve work processes for continued regulatory compliance and departmental efficiencies. Ensure compliance with applicable U.S, Canada regulations, laws, and standards. Katalyst Healthcares and Life Sciences