- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of ... Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to… more
- Boston Scientific (Maple Grove, MN)
- …and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of the Interventional ... or related discipline within the medical device industry (eg, R&D, Quality, Clinical , Medical Affairs , Biocompatibility) Introductory knowledge of US FDA and EU… more
- Conmed (Denver, CO)
- Job Summary: The Sr. Regulatory Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the ... guidance to other RA Staff and project team. Collaborate with quality, clinical , legal, commercial, and reimbursement teams to align regulatory strategies. Identify… more
- Boston Scientific (Marlborough, MA)
- …or 2 years work experience in a related discipline (eg, R&D, Quality, Clinical , Medical Affairs , Biocompatibility) in the medical device industry Introductory ... of all urology surgical procedures. This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development… more
- Boston Scientific (Maple Grove, MN)
- …reviews of supporting documents for inclusion in regulatory filings Review of clinical study protocols and other clinical documentation, and assessment of ... qualifications: Minimum of a Bachelor's Degree 7+ years of experience in Regulatory Affairs , or 5+ years of experience with an advanced degree (Master's or PhD)… more
- Intuitive (Sunnyvale, CA)
- …new product introduction, and manufacturing teams for assessing the impact of clinical strategy and design inputs and outputs on regulatory filings and compliance. ... and significant product changes in a timely manner. Support clinical study strategy and design as it relates to...Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist ] Experience: Minimum 5 years relevant experience working in… more
- Katalyst HealthCares and Life Sciences (Alameda, CA)
- …app-based devices (Annex I & XIII). Effective collaboration with software, clinical , and human factors team. Post-market compliance expertise, including UDI, ... vigilance, and software change reporting. Strong understanding of cybersecurity requirements and guidance (eg, FDA, IMDRF). Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.). Direct experience with… more
- Bausch Health (Bothell, WA)
- …Health Canada registration, CE Marking, global product registrations, and clinical evaluations/studies Regulatory affairs professionals responsible to complete ... Manager, Regulatory Affairs Medical Device-Aesthetics (Bothell, WA) 1 of 2...GSM (Global Strategic Management) team. Support and guide RA specialist who responsible for international registration cooperation, monitor regulatory… more
- Abbott (Boston, MA)
- …serve people in more than 160 countries. JOB DESCRIPTION: Job Title Principal Field Clinical Specialist Working at Abbott At Abbott, you can do work that ... currently have an opportunity available for a Principal Field Clinical Specialist to join our Vascular division....from the range posted. JOB FAMILY: Medical & Scientific Affairs DIVISION: AVD Vascular LOCATION: United States of America… more
- The University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center) Job ... Profile Title Clinical Research Quality Specialist C Job Description Summary The Abramson Cancer Center...in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality… more
- Edwards Lifesciences Corporation (Los Angeles, CA)
- Make a meaningful difference to patients around the world. As a part of the Field Clinical Specialist team, you will be a critical part of delivering our patient ... Regional Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory, and Education. After… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Sr. Medical Information Specialist is responsible for meeting the medical information needs of internal and external ... member of the department by collaborating cross-functionally to meet Medical Affairs objectives. This includes but is not limited to:Leveraging scientific expertise… more
- Globus Medical (Audubon, PA)
- …can resume their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for ... clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting Reviews Document Change Orders… more
- BioTalent (Westlake Village, CA)
- Senior Regulatory Specialist In your role as a Sr. Regulatory Specialist , you will develop and implement medical device regulatory strategies to obtain timely ... maintain regulatory licensing by jurisdictions. Work cross-functionally with R&D, Quality, Clinical , and Marketing teams to ensure regulatory requirements are met… more
- Cedent (Boston, MA)
- CRO Regulatory Specialist Job Description The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors ... field. Master's degree preferred. Experience: Minimum 5 years in clinical research with 3+ years in regulatory affairs... clinical research with 3+ years in regulatory affairs at a CRO or sponsor. Certifications: RAC (Regulatory… more
- The New School (New York, NY)
- The Community Care Specialist serves as a member of the Residential Education (RE) team to provide immediate non- clinical response for crisis or other critical ... involving students during night, overnight and weekend hours. The Community Care Specialist reports directly to the Associate Director of Student Behavior. The… more
- Piney Technical Services (Kansas City, MO)
- Full-Time/Part-Time Full-Time Description The Regulatory Specialist , located in Kansas City, MO reporting to Director Regulatory Affairs , is responsible for ... etc.) particularly pertaining to product registration dossiers. Prepare and review clinical trial protocols and review final reports. Maintain all product… more
- University of Pennsylvania (Philadelphia, PA)
- …(PPMC) as well as participation in the didactic series of the department. Clinical responsibilities may include the provision of pain management and clinical ... are encouraged to apply. The academic clinician track emphasizes clinical and teaching excellence. Are you interested in this...Medicine at the University of Pennsylvania Office of Academic Affairs website to learn more about the different tracks:… more
- Takeda Pharmaceutical Company Limited (New York, NY)
- …the plasma collection industry and/or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and ... Information (PDI). Refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable...the FDA approved training requirements for BioLife Medical Support Specialist Minimum of two years in a clinical… more
- Takeda Pharmaceutical Company Limited (Joliet, IL)
- …the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides ... You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable...the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or… more
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