- Bausch Health (Bothell, WA)
- …Bachelors Degree Required Life science or technical discipline preferred. Minimum 6 years regulatory experiences in MNC medical device company (aesthetic ... device is a plus). Demonstrates profound knowledge and expertise in Active Medical Device international regulations, focus on US/Canada/MDR and APAC is a… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI)....medical or other technical fields and Class III medical device experience are preferred + Some… more
- Meta (New York, NY)
- …scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... a regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... Description:** Johnson & Johnson is hiring for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join...for a **Principal Regulatory Affairs Specialist- Shockwave Medical ** to join our team. The position is **FULLY… more
- Abbott (Maple Grove, MN)
- …Regulatory Affairs departmental responsibilities and processes + Familiarity of medical device regulatory requirements and submission/registration ... be structured under Global Regulatory Services managing projects related to harmonized regulatory processes in Abbott's Medical Device Division. As an… more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- 3M (Maplewood, MN)
- …Public Health, Environment, Safety or other EHS program + Experience working in regulatory , medical device , product responsibility or EHSR corporate staff ... **Job Description:** **Job Title** Product Steward & Regulatory Affairs Specialist **Collaborate with Innovative 3Mers Around...may be eligible for a range of benefits (eg, Medical , Dental & Vision, Health Savings Accounts, Health Care… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- Sanofi Group (Morristown, NJ)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… more
- ManpowerGroup (Beachwood, OH)
- Our client, a leading organization in the medical device industry, is seeking a ** Regulatory Affairs Specialist** to join their team. As a Regulatory ... + 4+ years of experience in a regulated industry, preferably in Regulatory Affairs or medical devices . + Strong written and verbal communication skills in… more
- Edwards Lifesciences (Irvine, CA)
- …clinical investigations, etc.). . Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. . Other duties ... as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...negotiating clinical trial agreements and associated contracts in the medical device or pharmaceutical industry or at… more
- Pentax Medical (Montvale, NJ)
- …for a FDA regulated employer + Thorough understanding of domestic and international regulatory requirements for medical devices + Experience with reusable ... imaging devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs...Affairs Specialist Why JOIN Us? We are an established medical device leader that is preparing for… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Duties** + Strategic Leadership and Portfolio Alignment: + Facilitate development of global regulatory strategies for medical devices and digital health ... technologies and data-driven solutions can transform healthcare beyond traditional medical devices . This leadership role leads an...of Regulatory Affairs experience, ideally within the medical device or digital health industries. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving ... years prior regulatory affairs experience in the medical device industry, or a minimum of...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical devices … more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...regulatory requirements for medical devices … more
- Abbott (Alameda, CA)
- …documentation practices. + **Global Regulatory Strategy:** Develop and execute regulatory strategies for software-enabled medical devices , ensuring ... and mentor a high-performing QARA team with deep expertise in software quality, regulatory affairs, and medical device compliance. + **Post-Market… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international… more
- Dentsply Sirona (Milford, DE)
- …team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits ... implements regulatory strategies to obtain and maintain regulatory approvals for medical devices ...experience in regulatory affairs, preferably in the medical device industry. + Experience with leading… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a plus + ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices … more
- Kelly Services (Norcross, GA)
- … Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA Industry: Medical Devices ... Principal, Regulatory Affairs professional to manage pre-market regulatory activities for medical devices ,...* Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to… more
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