- Merck & Co. (Rahway, NJ)
- …approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk ... injection.-- Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new… more
- Merck & Co. (Rahway, NJ)
- …expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on ... launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design,...Product Working Groups to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Merck & Co. (Rahway, NJ)
- …Reporting to the Director responsible for this area, you will partake in medical device assembly and process development using semi-automated and automated ... as needed. Key Responsibilities: Experience with, and a fundamental understanding of medical device assembly equipment to enable development of product specific… more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience10+ years of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device … more
- Merck & Co. (Rahway, NJ)
- …to commercialization. -Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… 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
- Lundbeck (Fort Wayne, IN)
- …5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience Ownership and accountability for the ... patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Lundbeck (Waco, TX)
- …an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Apply knowledge of pharmaceutical and regulatory … more
- Lundbeck (Joliet, IL)
- …from an accredited college or university 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Eisai, Inc (Phoenix, AZ)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...customer stakeholders in a compliant way.Monitor operating costs and compliance with territory budget.Seek out mentorship to learn and… more
- Eisai, Inc (Boston, MA)
- …Area Business Leader- ADBachelor's degree with 10+ years of pharmaceutical, biotech, or medical device sales with 5+ years successfully hiring, developing, and ... local markets and healthcare systems).Experience working with pharmaceutical manufacturer compliance & regulatory requirements.Experience networking, establishing, and… more
- Chemours (Boston, MA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …Proficient + Computer skills - Proficient + Working knowledge of FDA regulations & other medical device regulatory compliance requirements - Proficient + ... necessary, to support the site ramp up plan. Ensure compliance with regulatory policies and standard: manage...+ Strong practical work experience (8+ years); experience in medical device , food or drug industries preferred.… more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance , and quality assurance ... accuracy and resolving outstanding lot inspections. + Work with Regulatory teams (US and international) to ensure compliance...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- Cognizant (Chicago, IL)
- …discovery, Global Pharmaceutical market and industry, including BioTech, Medical Device , Traditional Rx, enabling technologies and regulatory / compliance ... **Experience Partner - Life Sciences (Pharma / BioTech / Medical Device )** **Associate Director - Chicago/Midwest Remote** **Who we are:** We are Cognizant… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +...detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems +… more
