- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar...device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …preferred + RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs /Compliance experience in medical devices + Experience with ... to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Problem solve...documents required under risk files). + Knowledge of global Regulatory Affairs requirements, regulations, and standards +… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems.… more
- IQVIA (Washington, DC)
- …guidelines, and apply these to services provided. * Stay current on US medical device regulatory requirements. Qualifications: * Bachelor's degree required; ... least 3 years of consulting or client facing experience preferred; direct healthcare and/or medical device experience preferred. * Should understand medical … more
- Abbott (Pleasanton, CA)
- …Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in medical device manufacturing or other similarly ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- GRAIL (Durham, NC)
- …assurance, diagnostics, and/or regulatory compliance within the diagnostics, or medical device field. + Experience supporting regulatory inspections ... as they relate to clinical trial conduct + Understanding of appropriate global medical device /IVD requirements, such as: ICH E6 (GCP), European Union (ISO… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls (CMC) ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Advanced Degree (MS), with Ph.D. preferred. + 15+ years of seasoned biopharmaceutical/ device industry experience or with a regulatory agency, while leading ... as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA… more
- BeOne Medicines (Emeryville, CA)
- …formulation, analytical, manufacturing, QC, QA, etc.). * Experience in gene/cell therapy or/and medical device is a plus. * In-depth knowledge of ICH ... **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …a **maker of possible** with us. Reporting directly to the business unit Vice President of Medical Affairs , the Director of Medical Affairs has the ... responsibility to support the VP, Medical Affairs in providing medical , scientific and technical...investigation + Minimum of 10 years experience in the Medical Device /In Vitro Diagnostics industry required. More… more
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