- Merck & Co. (Rahway, NJ)
- …CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will ... experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturingExperience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Engagement, Medical Affairs , Market Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs , and ... the global TA strategy by working closely with global marketing and medical leaders. Embody NN leadership behaviors, embracing innovation, leadership over process,… 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
- J&J Family of Companies (Raynham, MA)
- … Medical Device Directives) is required. + Demonstrated expertise in medical device regulatory requirements and processes. + Outstanding project ... focus. + At least 3+ years of regulatory affairs or related/equivalent experience in the Medical Device sector. + Experience with US FDA Regulations… 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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …background is preferred. + Masters Preferred. + 6+ years in regulatory affairs or equivalent, medical device /IVD industry, including 4+ years leading ... The Sr. Regulatory Affairs Manager will work with...The Sr. Regulatory Affairs Manager will work with a high level...and/or multiple employees. Knowledge and Skills + IVD and/or medical device experience required. + 510(k) and… more
- Medtronic (Santa Rosa, CA)
- …+ Bachelor's degree required. + Minimum of 2 years of experience in regulatory affairs in the medical device industry. + Or advanced degree with a ... minimum of 0 years of experience in regulatory affairs in the medical device industry. **Nice to Have (Preferred Qualifications):** + Effective and… more
- Philips (Orange, OH)
- …fit if:** + You've acquired 12+ years (preferred) experience working in Regulatory Affairs within the Medical Device industry. Experience with SaMD, AI ... **Head of Regulatory Affairs , CT/AMI** **Your role:** +...Your skills include extensive experience and knowledge of global medical device regulations, requirements, and standards required.… 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
- Cordis (Irvine, CA)
- …will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry. **Responsibilities** + Lead ... advanced degree preferred. + 8-10 years of experience in regulatory affairs within the medical device industry, with a strong focus on PMA submissions. +… more
- Owens & Minor (Sioux Falls, SD)
- …professional and project management skills desirable + 3+ years' experience in Regulatory Affairs , preferably in a medical device company + Experience in ... stock purchase plan + Tuition reimbursement **Job Summary** The Regulatory Affairs Specialist I assists in the...publications regarding + convenience kitting, including drugs, cosmetics, and medical device products + Assists with the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …or life sciences. RAC accreditation or Post-graduate degree preferred. + 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
- Stryker (San Jose, CA)
- … Affairs or RAC certification preferred + 1-2 years of regulatory affairs experience within the medical device industry + Knowledge of FDA and ... available at www.stryker.com We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Endoscopy...international medical device regulations and standards (eg EU MDR) preferred $97,900.00… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …MS, Life Sciences) preferred + Minimum of five (5) years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry preferred. ... / Excel / PowerPoint). + Manages time efficiently. + Knowledge of global Regulatory Affairs requirements. + Strong organizational skills + Ability to represent… more
- Globus Medical, Inc. (Audubon, PA)
- …Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains...medical devices; + Experience in medical device development and registration of products… 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
- Caldera Medical (Westlake Village, CA)
- …with RAPS, ASQ, CQE preferred. * 3-5 years experience in International Regulatory Affairs preferably in the Medical Device industry. * Experience with ... regulatory specialist, you will develop and implement medical device regulatory strategies to...Excel, Office, PowerPoint, and Adobe). * Regulatory Affairs Certification (RAC). Who is Caldera Medical ?… more
- Abbott (Santa Clara, CA)
- …related disciplines. + Advanced degree or additional professional training in regulatory affairs (RA) + 5+ years' experience in Medical Device industry. ... the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Manager** to join our team on-site in Santa Clara,… more
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