- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... Quality and Regulatory Affairs . International Regulatory Affairs and Senior Leadership....Affairs , and/or a combination of Regulatory Affairs and Quality Assurance within the Medical Device… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs ( RA ) serves as the regulatory lead on relative Review Committees (RCs), for products in ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo)...device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional… more
- AbbVie (Lake Bluff, IL)
- …stay current with Global industry trends and best practices in combination product and device regulatory affairs , review and comment on changing regulation ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling -… more
- AbbVie (Irvine, CA)
- …on Clinical Outcome Assessment (COA) tools including digital and submission activities for device regulatory approvals in a variety of counties including EU, US, ... the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs colleagues. + Provides regulatory policy, intelligence… more
- Lilly (Indianapolis, IN)
- …areas relevant to drug discovery or development, eg epidemiology, toxicology, pharmacovigilance, regulatory affairs + Experience within Global Patient Safety or ... communities through philanthropy and volunteerism. **Purpose:** The purpose of the Medical Device Safety Scientist Associate Director role is to leverage… more
- Takeda Pharmaceuticals (Lexington, MA)
- …JD) preferred. * You have a minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 2 years' ... potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Ideal candidate has a minimum of 5 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 ... process improvements to address potential issues. Accountabilities: + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute… more
- Stryker (Mahwah, NJ)
- …Here are 10 reasons to join our Regulatory Affairs /Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers- regulatory ... Why RA /QA at Stryker? Are you interested in working...Learn more about our award-winning organization by visiting stryker.com ** Associate Manager, Quality Assurance NPI (Hybrid)** Stryker is hiring… more
- Abbott (Alameda, CA)
- …shipment of study devices and supplies to clinical sites and performing study device accountability. + Responsible for assisting senior staff in planning study ... for diversity, working mothers, female executives, and scientists. **The Opportunity** The Senior CRA will assist in the clinical execution and management of all… more
- Abbott (Alameda, CA)
- …staff, and clinical management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs + Flexibility in daily activities. + Proficient with ... devices and supplies to clinical sites. + Perform study device accountability and reconciliation. + Assist senior ...and final reviews of study data in preparation of regulatory submissions. + May interact with RA /QA… more
- Abbott (Alameda, CA)
- …be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Flexibility in daily activities. + Proficient with Microsoft ... Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. + Responsible for assisting senior staff in… more
- Integra LifeSciences (Princeton, NJ)
- …and evaluations + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... help improve outcomes. **SUPERVISION RECEIVED** Under direct supervision of Associate Director, Global Marketing - Surgical Reconstruction, TT **SUPERVISION… more
- BD (Becton, Dickinson and Company) (Sandy, UT)
- …the Sandy plant ensure proper representation of the plant in all legal, tax and any regulatory affairs as it concerns plant. Ensure that the proper image of the ... 2. Safety: foster and maintain a culture that prioritizes associate safety and create and operate systems to drive...the site ramp up plan. 5. Ensure compliance with regulatory policies and standard: manage compliance activities to ensure… more
- Abbott (Alameda, CA)
- …shipment of study devices and supplies to clinical sites and performing study device accountability. + Responsible for assisting senior staff in planning study ... their glucose levels with our new sensing technology. **The Opportunity** The Associate Clinical Research III will assist in the clinical execution and management… more