Ethicon, part of Johnson & Johnson Medical Devices Companies, is recruiting for a Senior Regulatory Affairs Specialist/Program Lead, located in Santa Clara, CA! Remote work is possible, but travel to the Santa Clara, CA site may be required based on project need.
Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery. This includes the MONARCH® platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.
Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing... dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
In joining our growing regulatory team, the Senior Regulatory Affairs Specialist will help Ethicon reach US and international regulatory (NPD) approval goals. You will be working closely with a fast pace exceptional engineering and clinical teams, supporting product development stages and generating submission ready documentation and authoring regulatory submissions. Additionally, this individual will support health authority communications and contribute to strategy development.
This position reports to the Director of Regulatory Affairs. Responsibilities:
- Manage, prepare, and submit regulatory submissions required for device approvals and registrations in the US and globally.
- Correspond and collaborate with international J&J colleagues on international approval efforts.
- 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, clinical, manager 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.
- Perform regulatory research to inform strategy.
- Assist research personnel, application specialists, and risk management specialists, to ensure clinical research and clinical evaluation are performed in accordance with regulatory requirements.
- Provide regulatory expertise to other cross-functional teams including for example marketing team through labeling material reviews.
- Support preparation of 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 technical file/design dossier audits.
- Other duties as assigned.
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.
Qualifications
Required:
- Bachelor's Degree in science, engineering or related field
- 4 years of regulatory experience in medical device development
- Strong independent regulatory submissions development experience
- Strong working knowledge of U.S. FDA medical device regulations and guidances
- Proven track record clearing medical devices to market in the US (Class II or III)
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and knowledge ISO 14971
- Excellent verbal and written communication skills; strong attention to detail
- Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks
- 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
- Approachable individual who provides a high level of teamwork and cross-functional collaboration.
- This position is located in Santa Clara, CA and may require up to 10% travel, domestic and/or international Preferred:
- Advanced Degree
- Experience in project management and/or people management
- Solid understanding of IEC 60601 series
- Familiarity with international regulations and guidance medical device market including clearance/approvals of new devices and changes to devices (such as Europe, China, Brazil, Japan, etc.)
Primary Location
United States-California-Santa Clara-5490 Great America Pkwy
Other Locations
North America-United States-District of Columbia, North America-United States-New Jersey, North America-United States-New York, North America-United States-California, North America-United States-North Carolina-Durham, North America-United States-North Carolina-Raleigh, North America-United States-Minnesota-Minneapolis, North America-United States-Illinois-Chicago, North America-United States-Massachusetts-Boston, North America-United States-Pennsylvania-Philadelphia
Organization
Auris Health, Inc. (6267)
Job Function
Regulatory Affairs
Requisition ID
2105960471W
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