Auris Health, a company of Johnson and Johnson, is currently recruiting for a Senior Regulatory Affairs Specialist to be located in Redwood City, CA.
Auris is a technology company defining the future of medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris 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 will help Auris reach US and international regulatory approval goals. You will be working closely with a fast pace exceptional engineering and clinical team, supporting the team 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 Director 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 European Design Dossier/Technical Files in compliance with MDD/MDR requirements and the Auris Health Quality Management System for new devices and for changes to commercial devices.
- Conduct regulatory evaluation of changes to Auris devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)
- 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.
- Prepare 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 and design dossier audits.
- A minimum of a Bachelor's degree in science, engineering, or other relevant disciplines is required. Master’s degree is preferred.
- Minimum of 4 years professional experience required
- A minimum of 2 years of regulatory experience in the medical device industry is required.
- Demonstrated track record of developing executable global strategies that align with business deliverables is preferred.
- Software as a medical device experience is preferred.
- Knowledge of US regulatory processes is required.
- Proven track record clearing medical devices to market in the US (510k or PMA including supplements) is required.
- Authored and cleared a 510k is preferred.
- Familiarity with international regulations regulatory approval processes for medical devices (such as Europe, China, Brazil, Japan, etc.) a plus.
- 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.
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 is required.
- Knowledge of CFR Part 820, ISO 13485, and ISO 14971. Working knowledge of IEC 60601 series is a plus.
- Experience in project management and/or people management a plus.
- Proven 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 Redwood City, CA 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.
United States-California-Redwood City-
Auris Health, Inc. (6267)