- Cardinal Health (Columbus, OH)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- Children's Hospital Boston (Boston, MA)
- 77488BRJob Posting Title: Regulatory Affairs and Education Manager , Clinical Research OperationsDepartment:Research- Clinical Research Core ... and Education Program in Clinical Research Operations (CRO). The Regulatory Affairs and Education Manager will work closely with clinical … more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage ... Hiring Experts. **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs (CMC) is responsible for… more
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Abbott (Alameda, CA)
- …monitor their glucose levels with our new sensing technology. The function of a ** Regulatory Affairs Manager , Advertising & Promotion** is to combine ... of assignments. Individual is recognized as a discipline expert and resource in regulatory affairs . + Must function independently as a decision-maker on … more
- Bio-Techne (Minneapolis, MN)
- …Our family of brands creates a unique portfolio of products and services. POSITION SUMMARY The Regulatory Affairs Manager at R&D Systems will lead a team of ... purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides...Regulatory professionals, working closely with the Sr. Director, Regulatory Affairs and the R&D Systems (RDS)… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. The ** Regulatory Affairs Manager , Advertising & Promotions** is responsible ... and build consensus with various cross-functional departments (eg Marketing, Scientific/ Clinical /Medical Affairs , Legal & R&D [Research & Development])… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at... regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and obtain and maintain Clinical … more
- Stryker (Portage, MI)
- …More information is available at www.stryker.com We are currently seeking a ** Manager , Regulatory Affairs ** to join our **Instruments** **Division** ... a hybrid role based in **Portage, Michigan** **.** The Manager , Regulatory Affairs is responsible...regions. Through close partnership with business unit, Marketing, R&D, Clinical , Quality, production and supply teams, the Manager… more
- AbbVie (North Chicago, IL)
- …Advise internal cross-functional team who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, ... will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada) are: 1. Responsible for… more
- Merck (Philadelphia, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... drug development or clinical experience, preference if this experience is in regulatory affairs . + Excellent communication skills (both oral and written). +… more
- Teleflex (Morrisville, NC)
- Clinical Affairs Manager Coronary (Remote) **Date:** Nov 6, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 50% ... make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides ...expertise, insight and support to clinical end-users, clinical sales specialist, sales team, Regulatory , Engineering,… more
- Teleflex (Phoenix, AZ)
- Sr. Clinical Affairs Manager -Coronary/Structural Heart **Date:** Nov 14, 2024 **Location:** Phoenix, AZ, US **Company:** Teleflex **Expected Travel** : Up to ... a difference in patients' lives. **Position Summary** The Sr. Clinical Affairs Manager provides ...expertise, insight and support to clinical end-users, clinical sales specialist, sales team, Regulatory , Engineering,… more
- Danaher Corporation (New Brighton, MN)
- …lives with diagnostic tools that address the world's biggest health challenges. The Sr. Clinical Affairs Manager is responsible for directly managing a team ... Minneapolis. This position will report to the Director of Clinical Affairs in the US and will...the currently approved protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements + Drive clinical schedule deliverables… more
- Spectrum Plastics Master (Tucson, AZ)
- …experience in a related field, and a minimum of 5 years directly related to Regulatory Affairs experience in the medical device industry + Current knowledge of ... under review. + Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance… more
- Medtronic (Santa Rosa, CA)
- …in a more connected, compassionate world. **A Day in the Life** The Regulatory Affairs Specialist provides global pre- and post-market support for coronary ... regulatory implications of changes to these devices. The ** Regulatory Affairs Specialist** is responsible for developing...14971, ISO 13485 and IEC 60601. + Experience with regulatory support of clinical trials. **Physical Job… more
- Envista Holdings Corporation (Brea, CA)
- …its Quality Systems. + Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs . + Work on ad-hoc projects when required. ... **Job Description:** **JOB SUMMARY:** The Regulatory Affairs Specialist is responsible for...digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions… more
- Abbott (Alameda, CA)
- …the Diabetes Division. As a manager , the function of an Associate Director Regulatory Affairs , APAC (Asia Pacific) is to combine knowledge of scientific, ... working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our Alameda,… more
- Medtronic (Boston, MA)
- …more connected, compassionate world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and ... registrations. + Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. + Monitors...+ Bachelor's degree with 4+ years of experience in regulatory affairs OR + An advanced degree… more
- Vanderbilt University Medical Center (Nashville, TN)
- …requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is ... days, in accordance with state guidelines. **Technical Capabilities:** + ** Clinical Expertise (Intermediate):** Demonstrates working knowledge of FDA LDT… more