- BD (Becton, Dickinson and Company) (San Diego, CA)
- …10 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD , Pharmaceutical or Biotech firm. + Minimum 5 years experience directly managing ... Quality professionals. + Demonstrated expert-level knowledge of QMS. + Ability to travel domestically and internationally, up to 25% + Strong leadership skills with demonstrated ability to deliver excellent results + Strong project management, team skills, and… more
- Abbott (Sylmar, CA)
- …of experience in a manufacturing environment. + Previous experience working with IVD equipment is strongly recommended. + Experience working in an FDA regulated ... environment is a plus. + Additional requirements include: + Excellent verbal communication skills + Ability to translate complex technical ideas into concise, communicable documentation + Strong PC skills - Word, Excel, PowerPoint + Ability to work under… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …are a plus + Proven experience in a regulated environment, ideally within IVD , medical device, or life sciences, with strong knowledge of design control, quality ... systems (ISO 13485), and regulatory requirements (FDA, IVDR, CE). + Demonstrated success leading new product development (NPD) or product lifecycle programs from concept through commercialization, with accountability for timeline, budget, and compliance… more
- ManpowerGroup (Des Plaines, IL)
- …and managing test procedures). + Knowledge of ISO 13485 and related medical device/ IVD regulations. **We are looking for candidates who are eligible to work in ... the US without sponsorship.** **If you're interested, please click the "Apply" button.** ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its… more
- Hologic (San Diego, CA)
- …analysis pipelines. + Proficiency and understanding of regulatory requirements for IVD submissions + Strong expertise in bioinformatics, computational biology, and ... statistical analysis, and experience with large-scale biological data. + Experience with high-performance computing (HPC) environments. + Strong communication and collaboration skills to work effectively with cross-functional teams. + Experience with data… more
- Hologic (Marlborough, MA)
- …complaints, and drive post-market improvements for electromechanical in vitro diagnostic ( IVD ) devices. In this role, you'll collaborate with design, manufacturing, ... and service teams to translate customer feedback into actionable solutions that enhance product reliability, durability, and serviceability. If you're passionate about problem-solving, quality engineering, and delivering meaningful outcomes that improve the… more
- Takeda Pharmaceuticals (Boston, MA)
- …partners and vendors. + Proven experience managing companion diagnostics or IVD programs. + Have background in understanding of drug-diagnostic co-development and ... regulatory pathways. + Experience with biomarker-driven clinical trials and clinical data integration. + Understanding of key considerations relevant to global regulatory requirements + Experience developing team culture, resolving conflicts, and driving… more
- J&J Family of Companies (Raritan, NJ)
- …coordination and compilation of global submissions for (new) In Vitro Diagnostics ( IVD ) and Medical Devices (MD) to Health Authorities (HAs). + Maintain appropriate ... external contacts and negotiate with HAs (US, EU, PMDA, and others) to obtain timely registration of the diagnostic products. + Provide guidance, support, and educational training to pharmaceutical project teams regarding in vitro diagnostic regulations and… more
- AbbVie (North Chicago, IL)
- …for Use (IFU) to ensure accurate device labeling New Product (Device, Combo, IVD ) Development Participates as a Core Team Member on New Product Development projects ... as assigned SOP Development & Training, Personnel Development + Contributes to the mentoring of colleagues in clinical safety management. Provide technical knowledge to Device Safety Analysts as needed + Develops and maintains comprehensive and current… more
- WTW (Charlotte, NC)
- …for associate coaching. + Conduct regular meetings with operation leaders within each IVD , via Teams or in person, when possible, to review and address challenges, ... and explore opportunities to include DSO efforts for sediment, cash on account and bad debt items. + Travel to field offices, including Manila and Mumbai, as needed, to build and maintain relationships, resolve client issues, address client needs, and meetings… more