Ethicon, part of Johnson & Johnson Medical Devices Companies, is recruiting for a Senior Regulatory Affairs Specialist , Advanced Imaging Software, located in either Cincinnati, OH or Redwood City, CA!
Remote work is an option, but travel to the Redwood City, CA site is 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 .
In joining the Digital Solutions team, the Sr. Regulatory Affairs Specialist will help reach US and international regulatory approval goals by providing regulatory guidance, creating global strategies, and preparing submissions (eg 510(k), De Novo, Technical Documentation, pre-submission meetings) for projects focusing on surgical visualization, technologies utilizing software Machine Learning and Artificial Intelligence, as well as collaborating cross-company. This role will focus on the US and EU markets and act as a liaison to develop strategies along with local regulatory partners for target counties including those located in APAC and LATAM. We are looking for a great teammate who is as driven to advance patient care as we are!
In this role, you will:
- Provide regulatory guidance to cross-functional partners with an emphasis on software, artificial intelligence, and machine learning utilizing strategic regulatory thinking along with technical expertise to develop and plan global regulatory strategies for new and marketed products
- Prepare regulatory documentation for submissions to Health Authorities per FDA and MDR requirements; prepare and participate in pre-submission meetings
- Provide support in preparation, writing and submission of global registration activities (ex Japan, China, Australia, Brazil) requirements
- Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
- Ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and Medical Device Regulation, ISO 13485 etc.)
- Support quality system and technical documentation file audits
- Identify regulatory process improvements and work to improve and implement robust processes
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
- B.A./B.S. within a technical-related field
- Minimum 5 years regulatory experience within a medical device company
- Strong working knowledge of U.S. FDA medical device regulations and guidance’s
- Previous experience with medical device software
- Working knowledge of how global regulations impact product registration
- A proven track record of developing and executing regulatory strategies that align with business deliverables
- Ability to work collaboratively as well as build and sustain positive relationships across multiple platforms
- Familiarity with international regulations and guidance in medical device market including clearance/approvals of new devices and changes to devices in US and EU.
- Excellent verbal and written communication skills; strong attention to detail
- Excellent organizational skills
- Must be highly organized with the ability to lead multiple projects/tasks simultaneously and optimally prioritize projects and tasks
- Ability to travel up to 10% domestic and/or international
- Ability to work at either the Cincinnati, OH or Redwood City, CA site
- Advanced Degree
- Familiarity with international regulations and guidance in medical device market including clearance/approvals of new devices and changes to devices (such as China, Brazil, Japan, etc.)
- Experience with health authority meetings/interactions
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