- 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 Yesterday - 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 Yesterday - 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.
ExpandApply NowActive JobUpdated 2 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.
ExpandApply NowActive JobUpdated Yesterday - 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-timeExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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 Today - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday - 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.
ExpandApply NowActive JobUpdated Yesterday
regulatory affairs specialist jobs
FEATURED BLOG POSTS
Why College Students Should Work While in College?
College is a special part of our lives. It’s a time when we prepare for our dream job while creating some of the most memorable moments in life. That said, college life can also be stressful. Not only do we have to spend long hours studying, writing and researching, but we also have to deal with increased tuition fees and living expenses.
5 Ways to Measure Candidate Experience
Your candidate experience is made up of 4 essential parts
How to Stall a Job Offer Politely
You did it! After several weeks of looking for a new job and undergoing grueling interviews, you finally have a job offer. Although this may be very exciting, accepting a job offer means that you’re making a long-term commitment to your future employer. So, even if you’re eager to leave your current job, this isn’t a decision you should take lightly.
How to Get a Job in a New City - Best Tips to Follow
When your dream job posts, will you be ready? What if that dream job was in a faraway city or a different continent…would you move for it? Most of us have dreamed about what it would be like to accept a job in a new place at one time or another. But when it comes to actually making a move, it’s usually the logistical details that give us pause. The key to job searching in a different location is to have a plan.
What is a Policy of Non-Retaliation & How to Create One
Your company probably has many policies in place – anti-discrimination policies, equal opportunity policies, ethics policies, and so on. However, it is important to re-evaluate whether you have a policy that covers every situation. Say for instance one of your employees submit a complaint in good faith to their supervisor. To their surprise, they are met with retaliation, such as demotion, defamation, or even termination.
When to Tell Your Boss You're Job Searching
The Bureau of Labor Statistics has found that individuals, on average, have 12.4 jobs throughout their working life. So regardless of where you are on the career ladder, it’s inevitable that at some point, you’ll begin looking for another job. That said, you might be wondering,
What Questions Can You Not Ask in an Interview?
It can be stressful to interview candidates to fill an open role at your company. Maybe your boss is on you to hire someone who’s absolutely perfect as soon as possible. Maybe you don’t have a ton of experience yet in conducting interviews. Whatever the case, there’s a lot to take under consideration when you’re the one in charge of interviewing. For instance, “What questions can you not ask in an interview?” may very well be running through your mind given its legal ramifications. Knowing exactly which interview questions are off-limits (and which are fine to ask) will boost your confidence as you continue to search for the ideal new hire.