- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Cytiva (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the Business ... and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in… more
- Cytiva (Pensacola, FL)
- …site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management ... Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA or EPA-regulated manufacturing… more
- Cytiva (Duncan, SC)
- …control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries.In-depth knowledge of regulatory requirements and ... related to contamination controls and sterility assurance.Ensure compliance with regulatory requirements and industry standards for sterility and contamination… more
- Beckman Coulter Diagnostics (Miami, FL)
- …and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical ... Device Regulation (IVDR) as well as all other applicable global regulatory requirements.Maintain oversight, tracking, metric reporting and escalation of issues while… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …support of the stability program, including review and implementation of regulatory requirements for the stability program.Coordinate with Quality Control management ... the creation, review and trending of data, to meet customer, industry and regulatory requirements and presenting data in graphical form and reports provided to… more
- Cytiva (Miami, FL)
- …Health Sciences, or a related field.Minimum 5 years of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device, or pharmaceutical ... providing quality leadership in manufacturing and design, ensuring compliance with regulatory standards and driving process improvements; leading root cause analysis… more
- Cytiva (Miami, FL)
- …engineering or project engineering role, preferably in healthcare manufacturing or medical device production.2+ years experience with regulatory standards and ... processes, managing projects, and ensuring the efficient production of high-quality medical devices and products in a regulated environment. The ideal candidate… more
- Cytiva (Miami, FL)
- …(QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring process.Who you are:Bachelor's degree in ... would be a plus if you also possess previous experience in: Medical Device, eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949#LI-OnsiteJoin our winning team… more
- Cytiva (Miami, FL)
- …(QE Complaints and Deviations).Ensure supplier compliance to QMS and regulatory requirements through supplier monitoring process.Who you are:Bachelor's degree in ... would be a plus if you also possess previous experience in: Medical Device, eg ISO 13485PharmaceuticalChemicalAutomotive, eg IATF 16949Speaking fluent SpanishCytiva,… more
- Xcelerate Solutions (Frederick, MD)
- Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking a Senior program analyst who will support Joint Program Executive ... Office for CBRN Defense (JPEO-CBRND) Medical Regulatory and Acquisition Strategy (MRAS) team. In this role, you will support the MRAS Team of medical … more
- Novo Nordisk (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- J&J Family of Companies (Spring House, PA)
- …by the Company. **We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.** **Purpose:** + Able to function as a ... experience is required. + At least 8 years of relevant clinical/ regulatory medical writing experience is required. + Experience in project management and… more
- Caldera Medical (Westlake Village, CA)
- …- To Improve the Quality of Life for Women! In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies ... submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU… more
- J&J Family of Companies (Santa Clara, CA)
- …of America **Job Description:** Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical ** to join our team located in **Santa ... of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for … more
- Nissha Medical Technologies (Buffalo, NY)
- … Regulatory Intern will be able to learn about the responsibilities of a Regulatory Department within a global Medical Device Business. This is a great ... opportunity for anyone looking to have a career in Regulatory , Quality and has an interest in Medical Device regulatory compliance. You will focus on… more
- Abbott (St. Paul, MN)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + Experience with ... device regulations and submissions. + Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and… more
- Abbott (Santa Clara, CA)
- …consultations, initial submissions, deficiency responses and approvals. Working knowledge of regulatory requirements for medical devices in other countries such ... regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and EU … more
- Actalent (Agoura Hills, CA)
- Description As a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU… more
- Takeda Pharmaceuticals (Boston, MA)
- …of new and revised prescribing information and packaging; strategically interprets scientific, medical , and regulatory data and information. + Providing advice ... years of experience in the biopharmaceutical industry (eg, safety, ad promo, regulatory strategy, medical affairs, etc.). Up to 3 years of direct experience in a… more
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