- Olympus Corporation of the Americas (Center Valley, PA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** The Senior Specialist , Regulatory Affairs Operations - Regulatory Intelligence ... regulatory intelligence process. **Job Duties** The Senior Specialist , Regulatory Affairs Operations -...Has a broad understanding of the global medical device regulatory landscape, regulatory submissions (eg,… more
- Teleflex (Morrisville, NC)
- Principal Regulatory Affairs Specialist **Date:** Nov 1, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% ... solutions that make a difference in patients' lives. **Position Summary** The Principal Regulatory Affairs - Strategic Operations position will focus on the … more
- Integra LifeSciences (Braintree, MA)
- … regulatory strategies, and revise technical documentation for existing and new regulatory submissions . + Aid Supervisor in the development of US and ... possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level...draft submissions under supervision. Ensure timeliness of regulatory submissions according to business needs. This… more
- ConvaTec (NJ)
- …reach millions more. Join us on our journey to #ForeverCaring as a Senior Regulatory Affairs Specialist , and you'll drive progress that really means something. ... In this role as a Senior Regulatory Affairs Specialist at Convatec, you will...and Responsibilities** : + Preparation and submission of submit regulatory dossiers (US FDA 510(k) submissions ; EU… more
- Teleflex (Chelmsford, MA)
- Sr. Regulatory Affairs Specialist **Date:** Nov 21, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,...will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to… more
- West Pharmaceutical Services (Exton, PA)
- …software and regulatory tools. + Proven track record of successful regulatory submissions and interactions with regulatory authorities. + Experience ... Sr. Specialist , Regulatory Project Management (Evergreen Posting)...regulatory team through all project phases to support submissions including Premarket Notifications, Technical Documentations under EU MDR… more
- Amazon (Bellevue, WA)
- … regulatory strategies for new and modified products. * Prepares and submits regulatory submissions to health agencies. * Interprets new or existing ... the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to...and vendors. * Reviews protocols and reports to support regulatory submissions . * Creates, reviews and approves… more
- Kelly Services (Brea, CA)
- …or enhanced + Technical writing of procedures and/or SOPs that link to the regulatory operations + Represents and provides regulatory guidance within the ... Russia/CIS, China, and MEA-T) + Coordinates, prepares, and maintains regulatory submissions , product clearances/approvals, certifications, facility registrations,… more
- Abbott (Santa Clara, CA)
- …to support of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government ... heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist II** to join our...operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply… more
- Abbott (Sylmar, CA)
- …compliance with applicable regulations. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as ... employees, customers, contractors, and vendors. + Provides mentoring and leadership to Regulatory Specialist I and II team members **Required Qualifications** +… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Provides guidance to investigators and study teams regarding completion of IRB regulatory submissions (eg, new project applications, activation, amendments, and ... The Regulatory Affairs Specialist (RAS) positions provides...regulations apply to their research, consultation and education regarding regulatory requirements, review of FDA submissions for… more
- Integra LifeSciences (Boston, MA)
- … strategies, and create and revise technical documentation for existing and new regulatory submissions . + Prepares regulatory strategies with minimal ... to questions with minimal supervision. + Ensure timeliness of regulatory submissions according to business needs. This...and international regulatory teams. + Coordinates with Regulatory Operations for updates to the Unique… more
- Novo Nordisk (Plainsboro, NJ)
- … Specialist supports the development of labeling activities for all regulatory submissions . This individual collaborates cross-functionally and applies skills ... Affairs labeling related issues. Relationships Reports to labeling management in Regulatory Operations and Innovation. Develop and maintain positive rapport and… more
- Abbott (Austin, TX)
- … regulatory understanding to support products and teams and will prepare US regulatory submissions and/or registration documents for the US FDA as well as ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist III** position will work on-site out… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and execute actions necessary for BLA License supplements and other regulatory submissions to ensure that Grifols Plasma Operations is in compliance with ... business objectives are met. **Primary Responsibilities:** + Compile and process regulatory submissions through coordination with other departments and research… more
- Kelly Services (Sunnyvale, CA)
- **Kelly Science and Clinical is hiring a Regulatory Affairs Process Specialist to work with one of our biotech companies specializing in molecular diagnostics - ... to someone in US Central or Pacific time zone **Job Description Summary** The Regulatory Affairs Process Specialist will work with the SAP (ERP System) software… more
- Abbott (St. Paul, MN)
- …treatment of structural heart disease. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist ** to join our team on-site in St. Paul, ... MN. This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may… more
- Abbott (Santa Clara, CA)
- …the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist ** to join our team on-site in Santa Clara, ... CA.As an individual contributor, the function of a Regulatory Affairs Specialist II is to provide...the input of cumulative product changes to current product submissions . + Shares knowledge with others in department and… more
- Stanford University (Stanford, CA)
- Regulatory Specialist **School of Medicine, Stanford, California, United States** Research Post Date Nov 12, 2024 Requisition # 105179 TheBlood and Marrow ... for patients worldwide. BMT-CT is seeking a Clinical Trials Regulatory II Specialist to support a very...(OSP) and APB (Biosafety Committee). **Duties include:** + Prepare regulatory submissions (such as IRB and IND/IDE)… more
- University of Southern California (Los Angeles, CA)
- … Regulatory SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/Clinical-Research- Regulatory - ... Preferred Field of Expertise:Three years' experience in clinical research compliance, regulatory research and/or operations in the academic or private… more