- 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 ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… 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 ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … 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)
- …( our Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional… more
- Merck & Co. (Durham, NC)
- …Experience and Skills: Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination ... Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for...development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485:2016, EU … 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 ... and The Villages locations. This role is essential in providing high- quality cardiac device monitoring and patient care in a dynamic and patient-focused… 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) ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced… more
- BioSpace (Washington, DC)
- …Degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics 10+ years in Medical Device /Pharma/Biotech sectors Knowledge of quality systems ... suppliers. Lead a team of quality professionals overseeing external mechanical device suppliers Ensure compliance with scientific, regulatory , and quality… more
- Kaiser Permanente (Bellevue, WA)
- Description: DEVICE RN - EXPERIENCE IN EP, ED, CCU, PCCU Job Summary: Provide nursing care to a defined group of patients, adhering to Kaiser Foundation Health Plan ... the organization. Remains flexible to changing systems; is expected to demonstrate quality and effectiveness in work habits and clinical practice; and treats… more
- Michael Page (Hudson, NH)
- …in improving lives & advancing tech About Our Client My client is a medical device manufacturer specializing, supporting a variety of surgical fields (eg, ... 2-5 years of experience in a lean manufacturing environment, preferably within the medical device sector. Ability to identify issues, analyze root causes, and… more
- LivaNova, PLC (Houston, TX)
- …BS degree in Engineering or MS in Engineering Experience in a medical device manufacturing, quality system and regulatory environment Thrives in a ... challenges and importance of maintaining a healthy relationship Class III medical device (implantable) Experience/knowledge about manufacturing processes such as… more
- BioSpace (Pleasant Prairie, WI)
- …are determined to make life better for people around the world. The Device Assembly and Packaging (DAP) Operations Sr Director is responsible to provide leadership ... is a key member of Kenosha Site Lead Team ensuring safety, quality , and operational excellence. Key Objectives/Deliverables Provide Health, Safety and Environmental… more
- PENTAX Medical (Montvale, NJ)
- …role is vital to the production and quality assurance of PENTAX Medical Endoscopes. Responsibilities of Medical Device , Endoscope Inspection Technician: ... is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic...provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Medical Device… 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
- BioSpace (Indianapolis, IN)
- …Expert (SME) Oversight : Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you ... technical change agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance process. Engage… more
- Cleerly (Denver, CO)
- …regulatory landscape changes, particularly for AI/ML standards and Software as a Medical Device (SaMD) regulations. Regulatory Intelligence & Policy ... and develop senior regulatory professionals, guiding them through complex regulatory scenarios, including AI/ML medical device issues. Requirements… more
- Noah Medical (San Jose, CA)
- …guidance. Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory ... to revolutionize robotic surgery. About The Team Join our Quality team at Noah Medical , where you'll...of Engineering work experience with a BS in the medical device or similarly regulated industry or… more
- ClearPath Medical (Tustin, CA)
- …medical cable assemblies. We deliver high- quality , compliant solutions to the medical device industry. Located in Tustin, CA, we pride ourselves on ... Minimum of 3 years of experience in manufacturing or production supervision, preferably in medical device manufacturing or a regulated industry. At least 1 year… more
- Medtronic (Irvine, CA)
- …of relevant experience Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs This is not a remote position Nice To ... Have 4 years of experience in medical device regulatory affairs Excellent... Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Detail-oriented Ability… more
- Capstan (Santa Cruz, CA)
- …BS Degree in a scientific discipline; MS degree is a plus. Minimum of 8 years of regulatory experience in the medical device industry; 6 years with a Masters ... study documents, product registrations and licensing applications. Review product design, quality , and manufacturing changes to assess regulatory impact and… more
