- Sanofi Group (Morristown, NJ)
- …supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part ... team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug… more
- Sanofi Group (Morristown, NJ)
- …supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part ... developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in...+ Contribute to internal regulatory processes and procedures for MD/ IVD + Accountable for regulatory assessment for MD/ IVD… more
- Sanofi Group (Morristown, NJ)
- …supporting the medical device, combination product, digital health and in-vitro diagnostic ( IVD ) products within the Sanofi portfolio of products. The team is part ... team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug… more
- Bristol Myers Squibb (Princeton, NJ)
- …scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/ IVD preferred), cross-functional leadership, and a commitment to innovation in early ... diagnostics and biomarkers, with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global… more
- WTW (Short Hills, NJ)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …clinical diagnostics, CDx development, or regulated bioanalysis within pharma, biotech, or IVD settings. + Hands-on expertise in IHC (required and primary focus); ... additional experience in NGS, PCR, and flow cytometry strongly preferred. + Proven track record in CLIA lab operations, assay validation, design control, and regulatory submissions. + Familiarity with CRO/vendor management, ligand-binding immunoassays, and… more
- Abbott (Princeton, NJ)
- …**4+ years in healthcare marketing, sales, or technical roles ( IVD or medical devices preferred)** **Clinical experience (eg, laboratorian, perfusionist) ... highly valued** **Proven success in product launches and downstream marketing** **Strong communication, project management, and cross-functional leadership skills** **Ability to thrive in a matrixed environment and drive results collaboratively** **Learn more… more
- Roche (Branchburg, NJ)
- …field, ideally with expertise in Companion Diagnostics. + Knowledge in IVD , Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP's ... and QSR's, ISO13485 and 27001. + Experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China) + Strong track record of building and nurturing capabilities such as technical regulatory knowledge,… more
- WTW (Short Hills, NJ)
- …mentor to other ACAs, a partner/ team member for others within your IVD , or an ACA Leader. Note: Employment-based non-immigrant visa sponsorship and/or assistance is ... not offered for this specific job opportunity. **The Role** + Retains existing book of business, develops, and strengthens client relationships + Identifies, engages, and integrates delivery of all WTW internal resources to deliver an exceptional client… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …is preferred Experience + At least 3 to 5+ years' work experience ( IVD , Medical Device, Pharmaceutical or consulting experience is preferred) + Business experience ... may include marketing, sales, sales training, business development Knowledge, skills and abilities + Proactive self-starter with the ability to thrive in a fast-paced, dynamic environment + Strong action orientation with excellent prioritization and… more