- UpvoteDownvoteShare Job
- Suggest Revision
Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
RemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
As part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Regulatory Affairs Specialist will be responsible for supporting regulatory strategy, conducting regulatory research, producing technical reports to support regulatory implementation or commercialization of new products and processes in the dental/orthodontic area.
ExpandUpdated 29 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
ExpandUpdated 27 days ago - UpvoteDownvoteShare Job
- Suggest Revision
A Regulatory Affairs/Safety Officer Specialist ensures compliance with all OSHA requirements, supports GMP compliance activities by participating in audits, preparing for regulatory inspections, reviewing procedures, and maintaining error-reporting systems.
Full-timeExpandUpdated 27 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory affairs experience in the medical device industry with a track record of successful submissions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
RemoteExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Provide ongoing support to project teams for regulatory issues and questions. Interact and negotiate with regulatory agencies on defined matters as needed. Assist in the maintenance and improvement of regulatory SOPs.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Be energized by joining a world-class company and regulatory team. Strong communication and regulatory writing skills. Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Senior Regulatory Affairs Specialist. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Abiomed's "Patients First!" Senior Regulatory Affairs Specialist.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Remote work options may be considered on a case-by-case basis and if approved by the Company. Ability to comprehend principles of engineering, physiology and medical device use. Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA.
ExpandUpdated 28 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
ExpandUpdated 28 days ago
regulatory affairs specialist jobs
FEATURED BLOG POSTS
Is There a Slow Decline of the Labor Market and Wage Growth?
BLS data from January 2023 to March 2023 states that,
2023 Quarterly Review: What’s Happening in Recruitment?
It’s that time again. It’s your quarterly review. Get excited because this is a great time to review some of the amazing accomplishments you and other pros like you have made in recruitment for 2023 thus far! Despite recruitment challenges, things are starting to balance out in the candidate market - partly because of the brilliant ideas and methods being used.
Project Coordinator Resume Guide with Tips and Samples
Project coordinators fall within the field of project management, which tends to be a field with a lot of opportunity. In short, project coordinators differentiate themselves from project managers due to the responsibilities related to their work. While project managers have a hands-on approach for managing a team, project coordinators ensure the success of a project from the background. They handle administrative and organizational tasks related to delegation, establishing project objectives, or performing digital administrative tasks.
Land a Production Supervisor Job With These 5 Resume Tips
Have you been working as a team lead on a factory floor or in a manufacturing plant for several years? Do you consider yourself a leader who excels at managing and coaching others? Can you monitor and optimize production processes? Do you recognize the importance of employee safety and compliance? If you’re answering yes to all of these questions, then you’re definitely in the right place.
Assistant Manager Resume Guide
It can be very challenging for many individuals to find a job in the current economy. As a result, the unemployment rate is only starting to decrease after being at its highest since the Great Depression. One of many reasons this is occurring is because this pandemic has encouraged people to quit their jobs to search for better working conditions, become entrepreneurs, or change careers.
The Ultimate Guide to Writing a Stellar Sales Manager Resume
Have you been working in sales for several years now and feel ready to move up the career ladder? Do you enjoy leading sales teams and developing strategies to drive company sales? Would you describe yourself as a strong communicator, negotiator, and closer? If so, then there’s a good chance that a sales manager position might be the ideal fit for you.
The Ins and Outs of Building a Resume From a Bar Manager Job Description
Many people turn their noses up at bartending jobs, as they do for most jobs in the food service industry. Little do they know, bartenders possess a lot of unique skills. Even though these jobs can require little to no education, bartenders must go through extensive training or schooling. Additionally, the demand for these jobs is extremely high, and the career growth opportunities often bring bartenders into management positions after years of experience.