- Vanderbilt University Medical Center (Nashville, TN)
- …. The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible for ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...goals and objectives. Continuously demonstrates a strong focus on quality in spite of time and other pressures. Anticipates… more
- MD Anderson Cancer Center (Houston, TX)
- …public. This position will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and applications. ... regulatory strategy, regulatory requirements for clinical studies, regulatory submission preparation and maintenance. Ensures high- quality and timely… more
- System One (Durham, NC)
- …an experienced QA Consultant to assist a biotech company in preparing for an FDA audit with a strong focus on Good Clinical Practice (GCP) compliance. The ideal ... of GCP regulations and extensive experience guiding companies through FDA submission readiness, ensuring documentation, processes, and practices meet all… more
- Actalent (Landover, MD)
- …monitor, and act accordingly to support ISO-GFSI compliance, FDA -FSMA regulatory requirements, Food Safety & Quality programs. This individual has ... work aids, and forms. + Support ISO-GFSI compliance and FDA -FSMA regulatory requirements. + Monitor and act...and supplies. + Reporting Quality Deviations to Quality Management. + Assuring compliance with regulatory … more
- Vanderbilt University Medical Center (Nashville, TN)
- …recommend amendments to study protocols, as appropriate. Assists with assuring adherence to FDA and other regulatory guidelines. QUALITY ASSURANCE (NOVICE) + ... do their jobs better by providing tools and support to improve the quality of research, publications, grant writing, and training for future doctors and researchers.… more
- Balchem (Faribault, MN)
- …+ Familiarity with GMPs for food and dietary supplements, with experience in FDA regulatory compliance and relevant quality standards. + Strong ... Ensure adherence to GMP protocols, regulatory requirements, FDA compliance, and relevant quality standards. + Contribute to ideation by bringing new product… more
- Integra LifeSciences (Boston, MA)
- …Lead during external audits (eg, Notified Bodies and FDA ). + Exceptional quality system and regulatory documentation writing and editing skills (eg, CAPA ... in the back room of external audits, and preferably experience with FDA inspections. + Quality Management Review Coordination and preparation. + Quality Plan… more
- Randstad US (Dandridge, TN)
- …and recommended action in accordance with company strategic plans, GFSI, and FDA regulatory requirements. + Serve as a quality systems team member on cross ... quality manager - food manufacturing. + dandridge ,...facility just outside of Knoxville, TN is seeking a Quality Manager to add to their team. This is… more
- Olympus Corporation of the Americas (Westborough, MA)
- …This position leads cross-functional team to investigate and develop responses to Quality / Regulatory compliance communications. Authors, leads and manages all ... Quality / Regulatory compliance...regulatory requirements, including but not limited to US FDA , EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and coordinating compliance response communications working cross functionally with Market Quality , Marketing, Operations/Ops Quality , Regulatory , Risk and ... familiarity with applicable regulatory requirements, including but not limited to US FDA , EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. + Fluent… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA...and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality / Regulatory Responsibilities: + Assist the Manager of ... applicable). + Ensure compliance to all SOPs and other regulatory and trade organizational requirements (eg FDA ,...etc.), under the direct supervision of the Head of Quality / Regulatory . + Assist the Manager of … more
- Cordis (Irvine, CA)
- …to remote. MedAlliance (Cordis) are seeking a highly skilled and motivated Principal Regulatory Affairs Specialist to join our dynamic team. This role will play a ... will possess strong clinical experience and a proven track record in regulatory affairs within the medical device industry. **Responsibilities** + Lead regulatory… more
- University of Washington (Seattle, WA)
- …well as ensure compliance with the SOPs/guidelines. This position may also perform Quality Assurance checks on regulatory files as needed and implement/maintain ... and institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution,... regulatory affairs to ensure timely submissions to regulatory bodies (IRB, FDA , sponsor, etc.). *… more
- Fortive Corporation (Everett, WA)
- …seven years' experience in Quality Assurance and three years' experience in Regulatory Affairs in an FDA regulated industry. + Four year's people management ... **About the Job** The Regulatory Affairs and Quality Assurance Manager...efforts, including, but not limited to: + Support for regulatory meetings with FDA . + External health… more
- ADM (Washington, DC)
- **90814BR** **Job Title:** Senior Counsel - Food Safety and Quality Regulatory - Washington, DC **Department/Function:** Legal, Compliance, Regulatory ... Security **Job Description:** **Senior Counsel - Food Safety and Quality Regulatory (Washington, DC)** This is an...on compliance with local and national food safety and quality regulations, including those promulgated by FDA ,… more
- Stratasys (Eden Prairie, MN)
- VP, Quality & Regulatory Affairs Location: Eden Prairie, MN, US Job ID: 53845 Category: Manufacturing & Operations **Stratasys is a world leader in 3D ... supply chains, and improve patient care. As the **VP, Quality & Regulatory Affairs,** you will lead...all relevant international, federal, and state regulations, including ISO, FDA , CE Marking, and other applicable standards. Lead the… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …documents for SRC and IRB review and approval. + Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
- Novo Nordisk (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Quality Assurance activities during pre-approval GCP and GMP FDA /EMEA/PMDA inspections. + Expands and precedes the organization's policies and procedures ... plans. + Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies. + Ability to build effective… more