- UpvoteDownvoteShare Job
- Suggest Revision
JOB DESCRIPTION Job TitlePrincipal Regulatory Affairs Specialist-CT/AMIJob DescriptionThe Principal RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
May oversee and direct the work of other Regulatory Affairs professionals. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Sr. Regulatory Specialist, LATAM will prepare and submit regulatory compliance documents with regulatory authorities, and advise on regulatory affairs that stem from the U.S. Company's activities in the Latin American (LATAM) region.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The Role Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
O Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Experience with complaint handling, quality & regulatory processes preferred. o Event reconciliation between EDC and Quality Assurance/Complaints. Clinical Safety Specialist.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Principal PQL supports efforts to establish collaborations between Regulatory Affairs, Process Development, MS&T, Analytical Development, Site Quality (QA/QC) and Internal/External Operations to ensure regulatory compliance of GMP operations in support of the assigned program.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
As the Safety, Quality & Compliance (“SQC”) Specialist of the Chick-fil-A Supply Distribution Center in Cartersville GA, you will support the application of regulatory compliance in multiple areas, including food safety quality assurance (“FSQA”) and environmental, health and safety (“EHS.
TemporaryExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
In conjunction with Quality Assurance, manages regulatory compliance for sponsor activities for CMC, drug supply, documentation, Good Manufacturing Practices (GMP) requirements as needed.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
The ICM System Regulatory Specialist is the primary point person for maintaining the system case management policies and procedures. Accredited Case Manager (ACM) - American Case Management Association (ACMA); California Registered Nurse (RN) - CA Board of Registered Nursing; Master's Degree; Certified Professional in Healthcare Quality (CPHQ) - National Association for Healthcare Quality; Bachelor's Degree; Certified Case Manager (CCM) - Commission for Case Manager Certification.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Today
regulatory affairs specialist quality systems jobs Title: sr regulatory specialist
FEATURED BLOG POSTS
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.
How to Take Your Careers Page to the Next Level
Your careers page deserves a lot of attention. It is not just another page on your website. It is a vital tool that could enhance your recruitment outcomes. But in order to do that, you have to make sure it's fully optimized.
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.
How to Prepare to Be Fired - What You Need to Do
If you’re reading this, let me be the first to tell you how sorry I am. Getting fired feels crappy, disheartening, hurtful, and all the other bad, sad words. But here’s what I want you to do. First, let yourself fumble for a minute. Then, pick your head up — sometimes getting fired is a blessing in disguise. If you think termination is around the corner, we’ll teach you how to prepare to be fired and what to do next so you land somewhere even better.
How to Find a Job That Makes You Happy - 11 Concerning Facts
Do you ever feel like your life is like one of those rom-com movie scene openers? You know, the ones where the main character rolls out of bed, awakened by a casually upbeat theme song, sulks their way to the coffee pot, and then trudges toward their computer to begin yet another boring day at work?
How to Decline a Job Offer You Already Accepted
When you think about it, turning down a job offer is not the worst position you could be in. If you’ve been lucky enough to consider multiple job offers, well, then you’re lucky enough.