- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Medtronic (Minneapolis, MN)
- …regulatory affairs **Nice to Have:** + 7+ years of experience in medical device regulatory affairs with roles displaying increasing responsibility ... + 1+ year of experience in medical device regulatory affairs program management + Strong project management skills with experience leading… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … or Science (or similar) is required. Master's degree preferred. + Experience in medical device Regulatory Affairs , Quality Assurance, or Research ... is likely not legitimate._ **Job Description** The Senior Specialist, Regulatory Affairs Operations - Regulatory ...activities. + Has a broad understanding of the global medical device regulatory landscape, … more
- Stryker (Mahwah, NJ)
- …in Engineering, Science, or related degree + Minimum 2 years of work experience in medical device regulatory affairs + Time management skills, writing, ... employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Joint… more
- Bristol Myers Squibb (Princeton, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Abbott (Atlanta, GA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist II** will work on-site out of our Atlanta,… more
- Eurofins (Boston, MA)
- …+ Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs , and quality management. + Foster a culture ... to support our clients in the medical device industry across their product innovation, regulatory ...entire product lifecycle, from pre-clinical and clinical support to regulatory affairs and market access. Key Responsibilities:… more
- Bayer (Pittsburgh, PA)
- …to ensure registration of products; + Support international registrations within the Radiology Medical Device Regulatory Affairs group; + Maintain ... Code:** 826166 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Regulatory Affairs , Compliance, Medical Device , Law, Radiology, Legal,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... / Machine Learning-enabled medical devices + Expert in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical devices.… more
- Medtronic (Minneapolis, MN)
- …+ Experience in medical device industry + Experience with regulatory affairs or quality + Intermediate knowledge of word processing, spreadsheet, ... annual reports, and FDA/ Regulatory Agency communications. Primarily interfaces with regulatory affairs teams, project leaders, and manager. Join a diverse… more
- Cordis (Irvine, CA)
- …**Experience:** 5 years of experience in technical writing, preferably in regulatory affairs or the medical device sector. + **Knowledge:** Familiarity ... are currently seeking a **Technical Writer** to join our Regulatory Affairs department, focusing on the development...with medical device regulations (FDA, ISO 13485, ISO 14971, and ISO… more
- San Jose State University (San Jose, CA)
- …experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs , clinical and ... discipline, and a minimum of 3-5 years related experience in a medical device , pharmaceutical, In Vitro Diagnostics, and/or Clinical Research Organization… more
- J&J Family of Companies (Santa Clara, CA)
- …duties as assigned. **Qualifications** Requirements + Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's ... & Johnson is recruiting for Senior Regulatory Affairs Specialist for Shockwave Medical Inc. located...medical , or other technical fields and Class III medical device experience are preferred. + Ability… more
- AbbVie (Irvine, CA)
- …objectives, both strategic and applicable regulatory requirements. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible ... for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical ...quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio. The role oversees generation and… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing...teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA… more
- Abbott (Sylmar, CA)
- …location in Sylmar, CA currently has an on-site opportunity for a **Senior Regulatory Affairs Specialist** with our Cardiac Rhythm Management division. This ... ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- J&J Family of Companies (Cincinnati, OH)
- …Engineering, or related field. + Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced ... & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Program Lead. The preferred location...Degree). + Experience with medical device regulatory new product… more
- Amazon (Bellevue, WA)
- …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. ... verbal, presentation, and organizational skills. - . Experience with medical device software requirements. - . Ability...dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug… more
- Englewood Lab, Inc (Totowa, NJ)
- …Bachelor degree (Life Sciences, Engineering, related profession) + Experience of drug, cosmetic, medical device regulatory process is a pre-requisite + ... Title: Regulatory Affairs Associate Reports to: Manager...industry or related experience in any combination of cosmetic, medical device , food, or pharma is required.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory ... it is likely not legitimate._ **Job Description** Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the… more