Topcon Healthcare Solutions (THS), headquartered in Oakland, NJ, is a leading software engineering company of the eye care industry. THS is responsible for R&D, engineering, marketing, sales, and support of software solutions to the global market.
Topcon's mission is to make the impossible possible, by constantly innovating optical, imaging, and measurement technologies and developing new and advanced image management and networking solutions. Our goal is simple: to provide the ophthalmic medical community with the most innovative and indispensable software solutions so that doctors and researchers can better serve patients, ultimately improving outcomes in eye and vision care. THS is newly established in 2017 to provide the most advanced software solutions to the global market. We focus on IoT, Cloud and AI technologies to enable “Healthcare through the eye”.
The Regulatory Manager for Topcon Healthcare Solutions will help streamline and speed our time to market and build quality in every step. Your expertise in regulatory requirements will be crucial in every step of our development and software solutions offerings. In this position, you will implement policies, procedures, practices and strategies for RA. Collaborate with R&D, Clinical, and Quality and other required functions to develop and execute regulatory strategies from product inception to product launch.
- Responsible for preparing the documentation and implementation of regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements. - Prepare 510(k), Technical File, CE Mark, and other related regulatory filings. Collaborate with R&D and clinical team to determine and execute pre-clinical test plans in support of regulatory submissions when applicable. Collaborate with Clinical to develop clinical trial plans and reports - Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies. - Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the Company’s products. - Participate in due diligence activities related to Mergers and Acquisitions of products and other companies. - Ensure the timely and accurate filing of regulatory documentation. - Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies. - Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. - Lead or compile all materials required in submissions, license renewal and annual registrations. - Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. - Monitor and improve tracking / control systems. - Keep abreast of regulatory procedures and changes. - Recommend strategies for earliest possible approvals of clinical trials applications. - Participating in risk management efforts with product development teams - Assessing and determining regulatory impact of proposed design changes - Documenting and appropriately communicating changes for cleared devices - Reviewing marketing material for regulatory compliance - Provide training on regulatory requirements - Manage GUDID requirements and GTIN database with team
Education & Experience: - Bachelors in engineering or science - 7+ years minimum in Medical device regulatory
Knowledge, Skills, and Abilities: - Demonstrated experience in preparing 510(k) submissions for FDA - Experience in medical device regulation, software experience preferred - An ability to act independently - An ability to manage and prioritize diverse and competing assignments - Ability to find a way to achieve business goals while staying compliant - Strong knowledge of the QSR, ISO 13485, EU MDD, GUDID - Successful history serving as RA representative on product development teams - Ability to work in a fast paced and dynamic environment - Knowledge of HIPAA and data privacy laws is a plus - Medical Device clinical trial experience, GCP a plus
Internal Number: 2018-2620
Topcon Medical Systems, Inc.
Topcon's Eye Care division offers a full line of innovative diagnostic equipment and software solutions for the refractive, retinal and surgical specialties. Topcon utilizes the latest cutting-edge technology to develop products that aid in the detection and treatment of a variety of eye diseases, including diabetic retinopathy, glaucoma, cataract, and macular degeneration.
All Topcon products are manufactured with utmost precision and developed with the goal of helping to preserve and restore vision. Topcon’s unique product line, which includes retinal cameras, slit lamps, Optical Coherence Tomography (OCT), and digital imaging systems, comprises the largest selection of precision optical equipment from any one manufacturer.
Our Connecting Visions™ initiative seeks to provide product integration through an all-inclusive networking solution. The Synergy Ophthalmic Data Management System provides the doctor with a state of the art web-based tool to capture, store and share images securely, as well as integrate with many EMR systems.
Topcon Medical continually strives for excellence in product development, manufacturing, and support service