- Merck (Rahway, NJ)
- …science, preclinical and clinical research. + In-depth knowledge of medical device development, regulatory requirements, and quality standards, with a ... development, due diligence assessments, and strategic partnerships in the pharmaceutical or medical device industry. + Ability to inspire, mentor, and develop… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …degree (BSN). Advanced degree preferred. + Minimum: 7 years' experience in a medical device , quality or regulatory affairs role, or a BSN with exposure ... to medical device patient safety. + Demonstrated experience conducting literature searches/reviews, design studies per scientific methods, and basic statistical… more
- Actalent (Jacksonville, FL)
- …environment and maintain positive communications and collaborations. Hard Skills + Medical Device Regulatory Affairs + Quality Assurance + GMP Medical ... Job Title: Regulatory Affairs Specialist Job Description We are seeking an experienced Regulatory Affairs Specialist to head their own projects and submit… more
- West Pharmaceutical Services (Tempe, AZ)
- …biology or equivalent. + Significant experience (10+ years) in medical device /pharmaceutical manufacturing, quality assurance, regulatory affairs, or a ... Sr. Quality Manager Requisition ID: 66480 Date: Sep 5,...Abilities:** + ** Regulatory Skills:** In-depth knowledge of medical device and pharmaceutical regulations and guidelines,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international experience ... and meetings with global health authorities + Reviews and approves medical device development design control documentation, including technology transfer… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …during the development process to ensure submission acceptance and approval + Manages the device regulatory strategy of high quality and compliant ... the highest level of ethical standards + Creates high quality , compliant regulatory device documents...8+ years of biotechnology, pharmaceutical or medical device industry experience + 5+ years of regulatory… more
- Abbott (Santa Clara, CA)
- …with diabetes from routine fingersticks. We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** to ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...or Plano, TX. This position is included in the ** Medical Device Regulatory Affairs Development… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience ... landscape in US to maintain contemporary knowledge of global medical device and combination product regulations, standards,...scientific, regulatory and business issues to ensure regulatory filings are of high quality and… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- AbbVie (Irvine, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: Manager, Medical Device Quality Systems is responsible for supporting ... the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical...emerging regulations and standards impacting AbbVie medical device and combination products. + Performs regulatory … more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …through early detection and mitigation, working closely with project leads, site quality , manufacturing, and regulatory functions. This individual is expected to ... Description: Drug Device Combination Product Manager is a position within the Global Quality Management department. This position is a Corporate Quality … more
- Bristol Myers Squibb (Princeton, NJ)
- …for medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, ... regulatory submission timelines. Collaborate w/ the manufacturing sites, device quality group, & product quality group for medical device safety… more
- Merck (Wilson, NC)
- …products. + Experience with injection molding and working with medical device suppliers. + Experience leading Quality Management System gap assessments ... MDCP Operations Lead position will serve as the primary medical device and combination product (MDCP) point...liaison between the site and global MDCP teams (Technical, Quality , etc.), providing hands-on shop floor perspective and advocating… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory ... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Danaher Corporation (Sacramento, CA)
- …Development + Experience in a regulated industry, specifically knowledge of IVD and the Medical Device industry The salary range OR the hourly range for this ... for Diagnostic Software Development Quality . We aim to provide high- quality , reliable, and regulatory -compliant products to support worldwide market release… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …our team. It's a great time to be a part of ZOLL!Job SummaryThe Medical Device Cybersecurity Technical Project Manager combines technical expertise with project ... management skills to drive cybersecurity initiatives across a portfolio of medical device products. This role involves hands-on work as well as overseeing the… more
- Merck (Rahway, NJ)
- …development including regulatory submission and approval processes. Including development drug- device combination product or a medical device component ... their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on… more
- Danaher Corporation (San Diego, CA)
- …5 years of quality assurance experience in a production environment in the Medical Device , Pharmaceutical or Life Science industry. + Prefer minimum of 5 ... which makes everything possible. This position is part of the Quality Assurance & Regulatory Affairs (QARA) team and will… more
- Bausch + Lomb (Bridgewater, NJ)
- …deadlines. + Other duties as assigned. **Requirements** **TECHNICAL COMPETENCIES:** Knowledge of medical device regulatory affairs discipline throughout the ... and FDA regulations relating to submissions and regulatory approval of medical devices. Knowledge of medical device product labeling processes for… more
- Merck (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 in a ... + Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and… more