- AbbVie (Irvine, CA)
- …to a PhD degree in a scientific field, plus 2 years' experience in regulatory affairs . + Experience in US medical devices regulatory affairs is ... Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US regulatory affairs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting… more
- ICON Clinical Research (Farmingdale, NY)
- …people in the sector, and you'll be helping shape an industry. ** Regulatory Affairs Manager - In Vitro Diagnostic (IVD) Medical Devices** **The role:** As a ... need to be experienced with In Vitro Diagnostic (IVD) Medical Device and CDx directives, regulation, and regulatory... project . You will also contribute to ICON Regulatory Affairs through your understanding of EU,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …various business areas (Marketing, Market Access, Sales Training, Communications/Public Relations, Legal, Medical Affairs , and Regulatory Affairs ). + ... and review submission packages, labeling revisions, and promotional materials for regulatory compliance. In addition,collaborateswith Medical Affairs … more
- STERIS (St. Paul, MN)
- Senior Manager, International Regulatory Affairs Biocides - Remote Req ID: 41369 Job Category: Regulatory Affairs St Paul, MN, US, 55102 Description: At ... around the globe. Position Summary The mission of the Regulatory Affairs group is to implement effective... compliance as assigned by upper management. + Provide regulatory guidance and support to project teams… more
- Amazon (Sunnyvale, CA)
- …as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. ... used to drive multi-million dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug and Biologics regulatory… more
- ICU Medical (Lake Forest, IL)
- Job Title Manager, Regulatory Affairs - Electromechanical Devices FLSA Status Exempt Work Arrangement Hybrid Position Summary The Manager, Regulatory ... * RAC Certification preferred. * Eight plus years of medical device industry experience with a minimum of five...industry experience with a minimum of five years in regulatory affairs with direct experience with 510(k)… more
- Cook Medical (Bloomington, IN)
- … bodies- Help align engineering procedures and project outputs with regulatory requirements- Assist various Regulatory Affairs staff with technical ... Overview The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA… more
- Stryker (Fremont, CA)
- …years' experience in an FDA regulated environment required + 5+ years' experience in medical device regulatory affairs required + RAC certification or ... to apply? Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory -… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting and developing global ... be based in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for strategic and operational … more
- Integra LifeSciences (GA)
- …challenging what's possible and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing...independently or with minimal supervision. + Ability to explain regulatory requirements and pitfalls to project teams… more
- Medtronic (Minneapolis, MN)
- …to fostering a diverse and inclusive culture. **A DAY IN THE LIFE** * Act as Regulatory Affairs representative on project transfer teams. * Plan and execute ... strategy for supplier transfer projects. You'll assess the regulatory impact of supplier transfers and lead project...experience strongly preferred * 4+ years of experience in medical device regulatory affairs with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **Sr Director, CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The Sr Director, ... CMC Regulatory Affairs for Small Molecules is responsible...members to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical… more
- Medtronic (Miami Lakes, FL)
- …+ Bachelor's degree in a technical discipline + Minimum 4 years of experience in regulatory affairs in the medical device industry with Bachelor's degree + ... requirements, as well as communicate that information to the Project teams. + Provide regulatory support for...Minimum 2 years of experience in regulatory affairs , in the medical … more
- Abbott (Alameda, CA)
- …math, engineering, or medical fields. + Master's degree + 1+ year of Regulatory Affairs experience within Medical Devices is strongly preferred. + Prefer ... technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist,** as part of the...of 2 years' experience in a regulated industry (eg, medical products, nutritionals, pharma, food). Regulatory area… more
- J&J Family of Companies (Irvine, CA)
- …Location** NA-US-California-Irvine **Organization** Medical Device Business Services, Inc (6029) **Job Function** Regulatory Affairs **Req ID:** 2406184334W ... Senior Regulatory Affairs Program Lead - 2406184334W...preferred. * Experience with change assessments for internationally marketed medical devices is preferred. * Project Management… more
- Taiho Oncology (Pleasanton, CA)
- …and contractors. Performance Objectives: + Responsible to represent the Regulatory Affairs position and decision in assigned Project Teams, due diligence ... Sr. Director, Regulatory Affairs Strategy Pleasanton, CA, USA...Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and is… more
- Teva Pharmaceuticals (West Chester, PA)
- …industry experience required + Minimum of 5 years in a related position in regulatory affairs project management (creating, filing and defense of major ... Project Manager, a key member of Global Regulatory Affairs , will be responsible to develop...rewarding choice** We offer a competitive benefits package, including Medical , Dental, Vision, and Prescription coverage starting on the… more
- Medtronic (Northridge, CA)
- …more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory ... from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions...Medical Device) + Ability to work effectively on project teams. + Must be able to manage multiple… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …in Regulatory Affairs , and/or a combination of Regulatory Affairs and Quality Assurance within the Medical Device industry. + Knowledge of ... **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible...with Legal and clinical team to ensure compliance with regulatory requirements. + Presents regulatory project… more