- 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
- 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)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … 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
- 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)
- …advanced degree (Master's or PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering, with at least 5 years ... role.Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly,… 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
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU Medical Device … more
- Cardiovascular Institute of Central Florida (Lady Lake, FL)
- …documentation in electronic medical records (EMR). Ensure compliance with regulatory guidelines and best practices for device management. Proficiency of ... Institute of Central Florida is looking for a qualified Device Technician - CVI Tavares & CVI The Villages...of Central Florida is seeking a skilled and detail-oriented Device Technician to join our team at our Tavares… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk's Rare Disease portfolio. The Rare Disease portfolio includes medical treatments, customer solutions, and devices across multiple Therapy Areas ... driving customer impact by overseeing 5D efforts including Data, Diagnostics, Drug, Device , and Digital strategy and execution for relevant TAs, aligned closely 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 ... go-to-market plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related… more
- VB Spine LLC (Allendale, NJ)
- …a biomedical, scientific, or related technical discipline Minimum 1 year of experience in medical device labeling and/or regulatory affairs Understanding of ... Regulatory Labeling Specialist Location : Leesburg, VA or...to ensure labeling accuracy, usability, and alignment with global medical device regulations. Candidates should ideally be… more
- Lexington Medical (Bedford, MA)
- …new products and global expansion. This is a terrific opportunity for an experienced medical device regulatory professional to grow with our company. ... Affairs, or other technically related field. 5-8+ years of experience in medical device regulatory affairs, including prior 510(k) submission and EU MDR… more
- Eisai, Inc (Salt Lake City, UT)
- …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
- CorDx (Atlanta, GA)
- … Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and ... advanced degree preferred. Minimum of 7-10 years of experience in regulatory affairs within the medical device industry. Proven track record of leading and… more
- Alphatec Spine (Carlsbad, CA)
- …generate an invoice. This position supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 1271, ... free and efficient 10-key data entry skills Experience with data entry; medical device purchase order / sales order experience a plus Professional demeanor… 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
- Stryker (Mahwah, NJ)
- …3+ years of experience in an FDA regulated industry 2+ years of experience in medical device regulatory affairs Thorough understanding of FDA, Europe, and ... international medical device regulations Experience drafting regulatory submissions for product approval Preferred RAC certification or Advanced Degree… 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
