- Boehringer Ingelheim (St. Joseph, MO)
- **Description** Manager The Manager , Regulatory Affairs (RA) Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function ... and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to… more
- ICON Clinical Research (NC)
- Senior Manager , Regulatory Affairs - IVD ICON...**What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a ... join us on our mission to shape the future of clinical development. Sr Manager , Regulatory Affairs - IVD Location: US Remote, Portland, OR area preferred We… more
- Olympus Corporation of the Americas (Westborough, MA)
- …supports the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements ... ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**...|| United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs … more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work ... their glucose levels with our new sensing technology. This ** Regulatory Affairs Manager - APAC**...experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs ,… more
- J&J Family of Companies (Irvine, CA)
- …Learn more at https://www.jnj.com/medtech We are searching for the best talent for a ** Manager , Regulatory Affairs ** . _The preferred location for this role ... and relocation assistance is not provided. **Purpose** : The Manager , Regulatory Affairs , is a...or equivalent experience in another relevant function such as Quality , Medical, Clinical, R&D ( _6+ years with Advanced… more
- GE HealthCare (Waukesha, WI)
- … discipline or a minimum of 8 years work experience. + A minimum of 4 years Regulatory Affairs / Quality Assurance experience + A minimum of 4 years' ... regulatory bodies globally. + Manages a team of Regulatory Affairs professionals as well as an...in own job discipline or field. Serves as best practice/ quality resource. Has awareness of latest functional developments in… more
- Olympus Corporation of the Americas (Westborough, MA)
- …applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- Dentsply Sirona (Milford, DE)
- …business relationships. + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, ... of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and...degree in a relevant field, such as life sciences, regulatory affairs , or a related discipline. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams. Position will be filled in either ... Foster City, CA or Parsippany, NJ. **EXAMPLE RESPONSIBILITIES:** + Represents regional Regulatory Affairs or may serve as Regional Lead on… more
- Roche (Indianapolis, IN)
- …be working closely with colleagues in other departments and other counties. As a Regulatory Affairs Manager focused on Companion Diagnostics (CDx), with ... love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the...regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage. + You have demonstrated… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities, Global Quality , Technical Operations, Business ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... affairs related to the development of novel therapeutics including quality , preclinical and clinical areas of drug development and the policies/procedures… more
- Astellas Pharma (Northbrook, IL)
- …& People Management** + Supports an environment to enable each member of the Regulatory Affairs team to optimally operate in the matrix environment of GRA, ... discipline associated with pharmaceutical development or product oversight; 3 years in regulatory affairs preferred. + Strong scientific knowledge and … more
- Abbott (Alameda, CA)
- …years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related ... with our new sensing technology. **The Opportunity** The **RA Manager ** will work on-site out of our Alameda, CA...with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA...indications and reimbursement. + Works with Product Development, Clinical Affairs , Quality , Management and other areas of… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a ... more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish… more
- ThermoFisher Scientific (Frederick, MD)
- …food is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs , you will play a crucial role in interpreting ... teams, such as Research and Development, Product Management, Marketing, Quality Assurance, Manufacturing and with Regulatory authorities. **Benefits**… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Philips (Plymouth, MN)
- …or more senior regulatory affairs specialists. Under the supervision of the Regulatory Affairs (RA) Manager or a more senior Regulatory ... **Intern - Regulatory Affairs - Minneapolis, MN - Summer...issues with RA Management. + Obtaining knowledge in global regulatory requirements. + Following Spectranetics Quality System… more
- Lowe's (Mooresville, NC)
- **Your Impact** The primary purpose of the Senior Manager , Regulatory Affairs and Marketplace Compliance is to lead the development and operationalization of ... and overseeing policies, processes, and controls that ensure compliance with regulatory requirements, internal policies, and industry best practices. The role… more
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