- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... Experience** + 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience + Experience with US FDA regulations (Title… more
- Sanofi Group (Cambridge, MA)
- …GRA Device representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory ... regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care... regulatory bodies and industry groups to influence medical device industry standards and regulations, ensuring… 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: Senior Regulatory Affairs Associate Collaborate with Innovative 3Mers Around...may be eligible for a range of benefits (eg, Medical , Dental & Vision, Health Savings Accounts, Health Care… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least 10… more
- Caldera Medical (Westlake Village, CA)
- …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
- System One (Malvern, PA)
- …or equivalent, in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern,...Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device… more
- Fujifilm (Macedonia, OH)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... fields of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death. +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Job Responsibilities** The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion ... years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred. * Experience working with external… more
- Chemours (Frankfort, KY)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… 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
- 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
- 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
- Edwards Lifesciences (Irvine, CA)
- …an impact:** + Provide high quality guidance and support to Edwards' on healthcare and medical device regulatory matters, including US and other medical ... potential legal risks. This role requires deep knowledge of global medical device -industry, including the regulatory landscape, authorities and frameworks,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …**Overview** As Staff Specialist, Regulatory Affairs, you will develop and implement medical device regulatory strategies to obtain timely approvals from ... years of practical experience regulatory affairs, with a focus on medical device systems + Knowledge of international regulatory requirements (eg, FDA… more
- Abbott (Alameda, CA)
- …+ Minimum of 5 years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or other regulated environment ... products. Manage staff whose team is responsible for filing Medical Device Reports to the FDA (US),...Function as a representative during audits, inspections, assessments by regulatory agencies, eg FDA for the medical … more
- Abbott (Santa Clara, CA)
- …years of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical ... Replacement device . This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions to support… more
- AbbVie (Irvine, CA)
- …team and provides regulatory guidance to ensure compliance with applicable medical device regulations for new products. + (If applicable) Manages direct ... discipline is highly desirable. + At least 10 years of regulatory experience in the medical device industry with global, US and international experience.… more
- Medtronic (Irvine, CA)
- …experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** **Nice ... To Have** + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding of relevant… more
- ManpowerGroup (Lake Forest, IL)
- Our client, a leading organization in the medical device industry, is seeking a Regulatory Affairs / Operations Specialist to join their team. As a ... or Computer Science related subject. + 2-4 years of experience in medical device electronic submissions to regulatory bodies. + Excellent knowledge of… more
- Hologic (Marlborough, MA)
- …we'd love to hear from you! **Knowledge** + Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements. ... and business needs. **Experience** + A minimum of 5 years of experience in Medical Device Regulatory Affairs, with a proven track record in domestic and… more
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