- Christus Health (Sulphur Springs, TX)
- …Quality Control/ Quality Assurance in accordance with MQSA programs and ACR, FDA , and State standards and regulations. Assures that all documentation is accurately ... recorded and kept in an organized manner susceptible to instant inspection if needed. Excellent communication skills are necessary. Responsibilities: Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of… more
- Kaiser Permanente (North Kensington, MD)
- …mammograms and breast biopsies following the guidelines of ACR and FDA . Essential Responsibilities: Performs mammography and other related breast imaging procedures. ... Performs and documents patient assessment/history related to procedures and provides patient care to meet patients needs. Assists physicians (radiologists, surgeons, other specialists) to perform image-guided diagnostic and invasive procedures (eg:… more
- Biolife Plasma Services (Dallas, TX)
- …(in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in ... a clinical or hospital setting More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower… more
- Biolife Plasma Services (Dallas, TX)
- …(in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in ... a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you… more
- Cleveland Diagnostics Inc. (Cleveland, OH)
- …initiatives. This position requires strong attention to detail, strict compliance with FDA cGMP and ISO 13485 regulatory requirements, and the ability to perform ... to SOPs, work instructions, and product specifications, ensuring compliance with GMP, FDA , and ISO 13485 standards. Operate and maintain production equipment and… more
- Biolife Plasma Services (St. Ann, MO)
- …(in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in ... a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you… more
- Insulet Corporation (San Diego, CA)
- …outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines * Generate requirement traces and reports as needed for regulatory ... a Product Lifecycle Management (PLM) tool * Knowledge of introducing innovative FDA regulated medical devices to market * General understanding of communication,… more
- Insulet Corporation (San Diego, CA)
- …outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines* Generate requirement traces and reports as needed for regulatory ... a Product Lifecycle Management (PLM) tool* Knowledge of introducing innovative FDA regulated medical devices to market* General understanding of communication, data… more
- UMG / DEL MEDICAL, Inc. (Bloomingdale, IL)
- …issues. * Ensure compliance with *IEC 62304 (medical device software standard)*, FDA regulations, and ISO 13485 quality standards. * Write and maintain technical ... documentation including requirements, design specifications, and verification protocols. * Support prototype builds, testing, and design validation. * Participate in design reviews, code reviews, and risk management activities. *Qualifications* * *Bachelor's… more
- Remington Medical Inc (Texas City, TX)
- …Knowledge of medical terminology, clinical procedures, and healthcare regulations (HIPAA, FDA , ICH-GCP) Documented track record of successful sales quota achievement ... Excellent written verbal communication and presentation skills, with the ability to explain complex technical information Ability to pass and account and hospital credentialing Availability to attend operations and procedures, sometimes outside of normal… more
- American Fence Company, Inc. (Phoenix, AZ)
- …a mix of modern E1 toolset development (NERs, BSFNs, UBEs, Orchestrator, AIS, FDA ) and legacy RPG coding for interfaces, or support of existing business-critical ... E1 applications, reports (UBEs), and business functions (BSFNs/NERs). Utilize E1 toolsets ( FDA , RDA, TDA, OMW, Orchestrator, AIS) to configure, enhance, and deliver… more
- Unknown (Oklahoma City, OK)
- …scale without overcomplicating Nice-to-have: experience in wellness or regulated CPG (Prop 65, FDA , Amazon policies). This Role Exists To * Run the company with ... precision * Keep the founders focused on product and vision * Scale Fygg into a category leader with discipline and clarity Travel Percent Less than 10% Functions CEO/President Skills P&L Management required Growth Strategy required Retail Operations required more
- Unknown (El Paso, TX)
- …role within regulatory affairs in the biotech or pharma sector. Expertise in US FDA regulations and global health authority policies is essential, as is a proven ... track record of successful NDA submissions and approvals. The role requires exceptional leadership, communication, negotiation, and stakeholder engagement skills. The ideal candidate will be a strategic leader with a deep understanding of regulatory affairs,… more
- Unknown (Woburn, MA)
- …technology environments is mandatory, with a proven track record in obtaining FDA approvals and leading successful CE submissions. The Vice President, Quality ... Assurance will also be expected to have extensive experience in people leadership, excellent communication skills, and the ability to work within cross-functional and multi-disciplinary teams. Key responsibilities for the Vice President, Quality Assurance at… more
- Unknown (Dallas, TX)
- …ability to manage multiple projects and work effectively under pressure. Experience in FDA regulatory and quality assurance matters is preferred. The role requires a ... professional who is adept at problem-solving, and decision-making, and who can lead continuous improvement initiatives within the legal department. Hiring Manager Title Executive Director, Associate General Counsel Travel Percent Less than 10% Functions Legal more
- Unknown (Phoenix, AZ)
- …background. Deep experience in a highly regulated field, particularly with FDA and healthcare regulatory frameworks, is strongly preferred. The role demands ... a proven track record in managing and developing legal teams, as well as experience in strategic business advisory and commercial, labor, and transactional legal matters. The ideal candidate will be a transformational leader, capable of making pragmatic,… more
- Unknown (Portland, OR)
- …cross-functional teams, and ensuring the compliance of promotional materials with FDA regulations and company policies. Applicants for the Vice President, Regulatory ... Affairs Oncology position at the company should have an advanced degree in a relevant scientific discipline, with a preference for a doctoral degree. A minimum of 15 years' biopharmaceutical experience, including at least 10 years in regulatory affairs in… more
- Unknown (Boston, MA)
- …include overseeing the statistical aspects of regulatory submissions, particularly with the FDA , and ensuring the quality and integrity of data analysis and ... reporting. The role demands a Ph.D. in biostatistics, statistics, or a related field, a minimum of 12 years of experience in the pharmaceutical or biotechnology industry, and a proven track record in regulatory submissions. The Senior Director will also be… more
- Unknown (San Francisco, CA)
- …a 'player/coach' with a strong background in life sciences, particularly in FDA -regulated environments. International and global experience, as well as expertise in ... working cross-culturally, are mandatory. The role requires a professional with a proven track record in talent and HR business partnering, and a deep understanding of all aspects of talent management, including organizational development, coaching, performance… more
- Unknown (Phoenix, AZ)
- …life sciences industry. Experience in healthcare regulation, including fraud and abuse, FDA for medical devices, data use and privacy, and anti-corruption, is highly ... desirable. The role requires a proactive, solution-oriented approach to legal issues and the ability to work with specialist attorneys on a range of legal matters. The Senior Counsel will also be involved in continuous process improvement initiatives within… more
