- Eclaro (Littleton Common, MA)
- …Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable. Extensive knowledge ... making of non-conformance through a deep understanding of Quality Systems Regulatory expectations. Reviews and approves Quality, Quality Control, Validation and… more
- Abbott (Santa Clara, CA)
- …and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... regulatory landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards, and guidance +… more
- Edwards Lifesciences (Irvine, CA)
- …negotiation and drafting, etc.). + Monitoring legal developments applicable to the Healthcare Regulatory and medical device spaces. + Other duties and ... and interests of the patients we serve. The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...+ Experience reviewing advertising and promotional materials in the medical device or pharmaceutical industry. Aligning our… more
- Fujifilm (Twinsburg, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... needs of healthcare across prevention, diagnosis, and treatment. Fujifilm's medical imaging portfolio includes solutions for digital radiography, mammography,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ MS preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... and guidelines related to Artificial Intelligence, Software as a medical device and Machine Learning. + Assess...in Regulatory Affairs for Software as a Medical Device and Class I/II/III medical… more
- Cordis (Irvine, CA)
- …related field. + **Experience:** 5 years of experience in technical writing, preferably in regulatory affairs or the medical device sector. + **Knowledge:** ... edit, and maintain clear and compliant IFUs and other regulatory documents for medical devices. + **Package...Familiarity with medical device regulations (FDA, ISO 13485, ISO 14971, and ISO… more
- Caldera Medical (Westlake Village, CA)
- …Life for Women! As a regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... 3-5 years experience in International Regulatory Affairs preferably in the Medical Device industry. * Experience with Class II medical devices, including… more
- LSI Solutions (Victor, NY)
- …to gather regulatory intelligence regarding updates to US and international medical device regulations, and supporting Rest-of-World (ROW) regulatory ... and/or medical records. + A rudimentary understanding of Regulatory principles that govern medical device companies. Level II + Bachelor's Degree or… more
- Medtronic (Danvers, MA)
- …applicant profile._ + 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… more
- Abbott (Plymouth, MN)
- …changes for compliance with applicable regulations. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Supports all ... scientific affairs function. **Preferred** **Qualifications** + 4+ years of related regulatory submission experience from medical device , pharmaceutical,… more
- Abbott (Plymouth, MN)
- …of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly ... scientific affairs function. **Preferred** **Qualifications** + 4+ years of related regulatory submission experience from medical device , pharmaceutical,… more
- Eurofins (Boston, MA)
- …strategic vision and team to support our clients in the medical device industry across their product innovation, regulatory compliance, and quality assurance ... + Build and lead a team of skilled consultants with expertise in medical device testing, regulatory affairs, and quality management. + Foster a culture… more
- West Pharmaceutical Services (Exton, PA)
- …21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including change controls, device complaint ... Sr. Specialist, Regulatory Project Management (Evergreen Posting) Requisition ID: 67683...submissions including Premarket Notifications, Technical Documentations under EU MDR ( Medical Device Regulation), and Master Files (DMF/MAF)… more
- US Tech Solutions (San Bruno, CA)
- …of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical … more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for...orthopedic medical devices; + Experience in medical device development and registration of products… more
- Spectrum Plastics Master (Tucson, AZ)
- …a minimum of 5 years directly related to Regulatory Affairs experience in the medical device industry + Current knowledge of FDA cGMPs, European Medical ... commonly used concepts, practices, procedures and business principles within regulatory submissions in a medical device...business principles within regulatory submissions in a medical device industry + Knowledge of Post… more
- Cordis (Irvine, CA)
- …candidate will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry. **Responsibilities** + ... related field; advanced degree preferred. + 8-10 years of experience in regulatory affairs within the medical device industry, with a strong focus on PMA… more
- J&J Family of Companies (Cincinnati, OH)
- … Device is required (4+ years with Advanced Degree). + Experience with medical device regulatory new product submissions required. + A demonstrated track ... + Previous experience with health authority meetings/interactions + Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility,… more
- Cardinal Health (Columbus, OH)
- …experience + 5-7 years Regulatory Affairs Experience, preferred + Majority of Regulatory Affairs experience in Medical Device industry preferred + You ... Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical...activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of… more
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