- Merck & Co. (Rahway, NJ)
- … Medical Devices , Manufacturing Automation, Mechanical Design, Mechanical Testing, Medical Device Manufacturing, Medical Devices , Method ... to high-volume clinical and commercial assembly equipment and processes for medical devices /drug delivery systems. Reporting to the Director responsible… more
- Merck & Co. (Durham, NC)
- …that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, ... Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... retention, testing and retesting of samplesProject Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… more
- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices , Mentoring Staff, Ophthalmology, Pathophysiology, People… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required 4+ years of proven ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (Rahway, NJ)
- …and design verification testing to develop value-added solutions for medical devices and combination products.Build and enhance device or combination product ... management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a...or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs, finance, NNGlobal, and other relevant ... plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related elements… more
- Aequor (Thousand Oaks, CA)
- …Client yet practical solutions to meet those needs Experience with combination products and device regulatory requirements and medical device development ... and engineering Preferred Traits: Passion for proactively identifying opportunities through creative modeling and data analysis Transform ambiguous business and technical questions into measurable and impactful projects Partner with multi-discipline digital… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with start-ups, technology companies, and other external partners across diagnostics, medical devices , digital health, digital therapeutics, and data analytics ... innovations and emerging technologies, including diagnostics, data, digital health solutions, medical devices , and precision health Global Partnership Influence… more
- Eisai, Inc (Nutley, NJ)
- …with 3+ years experience in two or more of: infusion, diagnostic, biologic, medical device , buy and bill, rare disease, specialty pharmacy, and/or neurology; ... systems (including buy & bill, specialty pharmacy, distribution models, medical device and/or biologics experience) strongly preferred.Additional commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of relevant experience preferredData management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Lundbeck (Edmond, OK)
- …from an accredited college or university 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Eisai, Inc (Phoenix, AZ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... oral markets with approved indications, helping targeted customers, such as Medical Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the… more
- CorDx (Atlanta, GA)
- … Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products. This role ... Experience: 4-6 years of regulatory affairs experience in the medical device or IVD industry. Experience supporting or managing 510(k) submissions and … more
- Prestige Recruiting Firm (Clearwater, FL)
- …What You Bring: Bachelor's degree in engineering or life sciences 6-12 years of regulatory affairs experience in medical devices ; aesthetics or consumer ... Pre-Market Regulatory Affairs Manager Remote Why Join Us: Be...IFUs, UDI/GTIN registrations Stay current on evolving regulations in aesthetics/ medical device markets Partner with Quality, Clinical,… more
- Elliquence (Baldwin, NY)
- …drill systems . The ideal candidate will have significant expertise in medical device development, regulatory compliance, cross-functional project ... affairs to prepare submissions for FDA 510(k) or other regulatory approvals for medical devices ....develop, and deliver necessary components, materials, and technologies for medical device projects. Manage relationships with external… more
- Lundbeck (Raleigh, NC)
- …an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must ... resources. Pharmaceutical Environment/Compliance - Apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas ... teams, including Field Sales, Marketing, Strategic Partnership and Engagement, Medical Affairs, Market Access and Public Affairs (MAPA), Customer Engagement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions ... the optimization and efficient utilization of the warehouse space.Assist in regulatory inspections, perform safety and quality audits, and answer relevant questions… more
