J&J Family of Companies Senior Regulatory Affairs Specialist (Specialist IV) in Cincinnati, Ohio
Johnson and Johnson Robotics and Digital Solutions, is currently recruiting for a Senior Regulatory Affairs Specialist (Specialist IV) to be located in Cincinnati, OH or remote for the right candidate.
J&J Robotics and Digital Solutions, formed out of Auris Health and Verb Surgical acquisitions, is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, J&J Robotics and Digital Solutions is building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures.
In joining our growing regulatory team, the Senior Regulatory Affairs Specialist (Specialist IV) will help J&J Robotics and Digital Solutions reach US and international regulatory approval goals. You will be working closely with a fast pace exceptional engineering and clinical team, supporting the instrumentation team for the robotic system through product development stages to generate submission ready documentation and authoring regulatory submissions. Additionally, this individual will support labeling reviews, design changes, and some post market agency reporting activities. We are looking for a strong team player who is as excited to advance patient care as we are through our medical robotics products. We operate in a fast-pace, dynamic, start-up environment and looking for a cultural fit. This position reports to the Manager of Regulatory Affairs.
In this role, you will:
Prepare, submit, and manage regulatory submissions required for device approvals and registrations in the US and globally.
Prepare, submit, and manage 510(k)s and contribute to European Technical Documentation in compliance with MDD/MDR requirements and the Quality Management System for new devices and for changes to commercial devices.
Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission. Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)
Assist the preparation of instructions for use in collaboration with cross-functional teams, e.g. Engineering, Clinical Development.
Assist research personnel, application specialists, and risk management specialists, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements.
Provide regulatory expertise to marketing team through labeling material reviews.
Collate and prepare all materials, reports and follow-up with Regulatory Agencies regarding recall activity.
Prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
Support quality system audits.
A Bachelor's degree in science, engineering, or other relevant fields with a minimum of 6 years of relevant (i.e. RA, QA, R&D) OR an advanced degree with a minimum of 4 years of relevant (i.e. RA, QA, R&D) is required.
A minimum of 4 of regulatory experience in a medical device development with strong independent regulatory submissions development experience is preferred.
Strong working knowledge of U.S. FDA medical device regulations/guidances and EU Medical Device Directive and Medical Device Regulations is required.
A demonstrated track record of developing and executing regulatory strategies that align with business goals is required.
Regulatory submission experience (i.e. 510(k), PMA, EU Technical Files etc.) is required.
Familiarity with international regulations and guidance medical device market including clearance/approvals of new devices and changes to devices (such as Europe, Korea, Brazil, etc.) a plus.
Previous experience with health authority meetings/interactions is strongly preferred.
Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and knowledge ISO 14971 is required.
Working knowledge of IEC 60601 series is a preferred.
Excellent verbal and written communication skills; strong attention to detail is required.
Excellent organizational skills. Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks is required.
Experience in project management and/or people management a plus.
Confirmed ability to articulate customer needs and feedback to the engineering and marketing organizations.
Strong learning skills for complex technology and presentation skills to be able to present complex technology in clear, concise, and comprehensive fashion.
Advanced analytical and problem-solving skills.
Ability to translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements.
An approachable individual who provides a high level of teamwork and cross-functional collaboration.
This position is located in Cincinnati, OH or can be remote for the right candidate. and may require up to 10% travel, domestic and/or international.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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