- 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
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager, Engineer or AuditorExperience working with drug- device ... has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees… 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
- Michael Page (Beverly, MA)
- …on the production floor About Our Client The organization specializes in a niche medical device market that has continued to change lives across the world. ... If you are interested in being hands on and growing a career in the medical device space, APPLY TODAY! Job Description The Assembly Technician will be… more
- Synectics Inc (Dublin, CA)
- …processes between facilities. Strong knowledge of regulatory requirements and quality standards for medical device manufacturing. Excellent project ... mechanical engineering background to join our team and oversee the transfer of medical device manufacturing processes from one facility to another, ensuring… more
- LanceSoft (Dublin, OH)
- …*Must be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing ... The Assembler I position will inspect, weigh, package, and sort out defective medical devices as required. Essential Duties & Responsibilities *Keep work area clean.… more
- AbbVie (Pleasanton, CA)
- …compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...work collaboratively with a team to design and develop medical products from initial concept through the transfer to… more
- Katalyst HealthCares and Life Sciences (North Chicago, IL)
- …to solve problems. Scientific writing skills. Previous experience in pharmaceutical or medical device fields. Previous Quality or regulatory experience. ... Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad range of experimental techniques and methods of data analysis. Independently design, execute and interpret… more
- Atrium Medical (Hudson, NH)
- …the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations. Participates in ... domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs Director with … more
- Masimo (Irvine, CA)
- …the incumbent will be a key person in making it happen. The incumbent's medical device regulatory expertise, organizational ability, and multi-tasking skills ... classification requirements for international submission; Experience with FDA/GMP requirements for medical device ; Experience in Quality Systems, per… more
- Michael Page (Merrimack, NH)
- …a growth focused environment About Our Client Our client is an established medical device manufacturer specializing in precision engineered products for the ... have: 5+ years of manufacturing engineering experience Experience in regulated industries ( medical device , aerospace, etc.) Proficient in SolidWorks and fixture… more
- Abbott (Santa Clara, CA)
- …design and development from a regulatory perspective. Strong knowledge of regulatory requirements for medical device labeling. Proficiency in SAP ... skills. PC and Microsoft Office experience. Preferred Qualifications: Experience with medical device labeling or labeling for highly regulated industry… more
- Rep-Lite (Detroit, MI)
- Medical Device Sales - Territory Manager Overview A rapidly growing medical technology company is seeking a Territory Manager to drive awareness and adoption ... a four-year college or university required. 3-5 years of sales experience in medical device or specialized pharmaceutical sales. Experience in urology or market… 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
- Foresight Diagnostics (Boulder, CO)
- …the ability to work collaboratively in a cross-functional environment. *Familiarity with medical device regulatory pathways and requirements. *Ability to ... to identify areas of non-compliance and recommend corrective actions. *Support medical device reporting, post-market surveillance, and vigilance reporting per… more
