- 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 28 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 28 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
How do Good Interviewers Prepare for Interviews?
Just like candidates take the time to research you and your company, you should take the time to prepare for the interview. Preparing for the interview doesn't just reflect well on your employer brand and create a better candidate experience. Preparation also helps prevent bad hiring decisions. Bad hiring decisions are usually a result of poor execution during the hiring process. However, going into an interview fully prepared and ready to evaluate candidates will help avoid bad hires. So, here are 6 interview preparation tips for employers.
How to Get a Union Job? A Step-by-Step Guide
A union job can significantly impact your job security, pay, and employment benefits. Whether this is your first job or you have years of experience, a union job can offer much-needed protection in a labor market where employees are hired and fired at will.
How to Write a Statement of Interest the Best Way
Your life's goal is to work for Company A. Their brand, their product, their reputation—it's safe to say you're a fan. The only problem is that their careers page never highlights the role that matches your skills and experience. It's a bummer for sure, but don't fret.
Should I Hire for Potential Over Experience?
The workforce is shifting every day. In fact, research from the World Economic Forum (WEF) shows over half of employees around the world will need to upskill or reskill by 2025. The rapid rise of digital literacy, automation, and new technologies will quickly supersede businesses that don't train ahead of the curve. With the dire need to invest in training, it's evident that hiring someone with experience isn't that much different than hiring someone without it.
How to Decide Between Two Job Offers: 10 Practical Tips
It’s arguably a good predicament to have. You’ve applied to many jobs, interviewed multiple times, and now find yourself with two legit job offers. Nice! But although this is a feel-good validation of everything you have to offer, a daunting choice lies ahead. How do you decide which job will be the best fit for you?
Why Work in Sales? 9 Reasons & Tips on Answering as an Interview Question!
Working in sales can be demanding and challenging, but it can also be gratifying. Sales is an excellent career with a clear path full of excitement and potential for growth. So, if you're contemplating careers and have wondered "why work in sales?", keep reading to determine if sales is a suitable role for you.
How to Fire an Employee
So… you've finally decided to let one of your employees go. Drafting the paperwork and corresponding with HR is the easy part, but knowing how to fire an employee is where things get complicated. In fact, it is one of the most challenging conversations to have in the workplace. However, it must be done, and it must be done with poise and tact. Not only should you keep your state law in mind, but you should also consider your former employee's wellbeing.