Manager - Regulatory Affairs (Hybrid) - Tempe

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: What would I do if this patient were my mom? · Provide supp ...

Support regulatory activities related to medical devices/in vitro diagnostic products. · ...

The Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. · ...

The Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. · We are seeking a highly mot ...

As a Regulatory Affairs Analyst at Caris Life Sciences you will be responsible for regulatory activities related to medical devices/ in vitro diagnostic products including supporting regulatory compliance activities for US and international regions. · ...

+ Develop and execute global regulatory strategies for Class II devices + Serve as the primary regulatory authority on product development teams providing strategic input from concept through commercialization + Act as the primary company representative in all interactions with t ...

The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions. · ...

The Regulatory Affairs Engineer is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. · ...

+Job summary · The Regulatory Affairs Specialist role is responsible for preparing and submitting documentation for FDA 510(k) submissions.++•Ability to work in a fast paced collaborative team environment+•Ability to handle multiple projects and coordinate cross functional teams+ ...

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. · ...

+The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). · +Minimum of Bachelor's degree preferably in Engin ...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions. · ...

We are seeking an accomplished Regulatory Affairs Manager with hands-on regulatory experience to architect and drive regulatory strategy for our most complex products. · ...

We are seeking a Regulatory Affairs Manager to lead our regulatory activities related to medical devices / in vitro diagnostic projects and applicable health authority submissions. · ...

We are seeking an accomplished Regulatory Affairs Manager with hands-on regulatory experience to architect and drive regulatory strategy for our most complex products. This role is pivotal in shaping the regulatory landscape for our portfolio, navigating novel regulatory pathways ...

The Regulatory Affairs Senior Specialist is responsible for product remediation projects and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. · This role will provide support for global product registrations ...

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. · ...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. This position requires a minimum of five years medical device regulatory experi ...

The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). This role also supports post-market regulatory compl ...

The Regulatory Affairs Engineer role involves preparing and submitting documentation for FDA clearance and international regulatory bodies. · ...