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Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks.. Oversee post-market surveillance, adverse event reporting, and regulatory audits.. 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred.. Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals.. Official offers are sent through Docusign after a verbal offer, not via text or email.
Associate Director, Regulatory Affairs - Global Labeling page is loaded. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area.. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.. The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is responsible for partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR and internal audits).. Under the direction of the Executive Director of Clinical Quality Assurance, establish key processes and maintain the Nurix GCP QA audit program, policies, and procedures.. Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.. Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities
We are partnering with a well established Biotech company here in the SF Bay Area as they search for their next Associate Director of Regulatory Affairs.. Oversee the planning, preparation, and submission of regulatory documents to global health authorities (e.g., FDA, EMA), including INDs, CTAs, DMFs, BLAs, and MAAs.. Partner with regulatory operations to build and maintain submission timelines and global regulatory plans.. Bachelor’s degree in Life or Health Sciences required; advanced degree (MS, PhD, PharmD) strongly preferred.. 8–10 years of industry experience in pharmaceuticals or biotechnology, with a minimum of 4–6 years in regulatory affairs.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease.. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.. This Regulatory Affairs Manager position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division.. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
The Director will be the Category Leader for the category assigned to them within the Strategic Sourcing and Procurement (SS&P) department. This individual will be the key point of contact for their category and will be responsible for providing strategic leadership, operational oversight, and administrative/HR management for direct reports and extended leadership for indirect reports. The Director, Sourcing will be a Category Leader for the Development Category encompassing Clinical Labs, Clinical Pharmacology, Translational Research, Global Patient Safety, Regulatory Affairs, Medical Affairs, Clinical Development, and Biometrics. This role will support outsourcing needs to advance Exelixis R&D efforts, including services such as consulting, medical science liaison, pharmacovigilance, quality assurance, central labs, local lab results integration, PK and immunogenicity bioanalysis, biomarker assays, ADME studies, and toxicology. Deep knowledge of outsourcing concepts, financial processes, contracts, regulations (FDA, EMA, ICH GCP), and industry standards.
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options.. Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life.. Represent 89bio regulatory affairs on internal clinical study teams and external clinical research organization and vendor interactions. 3+ years of pharmaceutical industry experience in regulatory affairs experience. Background investigations are required for all positions by 89bio, consistent with applicable law.
This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division.. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.. Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Sutro Biopharma, Inc. is looking for a Director, Regulatory Affairs Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, protocols, CSRs, INDs/ CTAs, and marketing applications.. Experience in oncology drug development is preferred.. Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, investigator brochure’s, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.. Strong analytical skills; ability to understand and interpret complex clinical and scientific data and formulate those data into a well-thought out and reviewer friendly manner.. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FRα)-targeting ADC in clinical studies.
Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices.. If you enjoy a mix of both tactical and strategic hands-on work with a strong group of Regulatory Affairs experts, please apply!. Location: Remote (or hybrid opportunity in the Bay Area if you prefer!). Stay current with industry trends and best practices in international regulatory affairs.. Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices.
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave. Senior Regulatory Affairs Specialist -Vascular (on-site). Senior Regulatory Affairs Specialist Vascular (on-site). Regulatory Affairs Manager Heart Failure (on-site). Regulatory Affairs Manager Vascular (on-site)
Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. The Medical Director is involved in the design, monitoring, data analysis, and interpretation of the Companys late-phase clinical trials in endocrinology. Collaborate withand serve as a clinical research resource forcross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development.. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.
Collaborate with marketing to review and approve product marketing claims, ensuring compliance with FDA regulations and guidelines.. Collaborate with the quality team to ensure that the companys Quality Management System (QMS) meets regulatory requirements and is effectively implemented.. Review complaint decision trees and handle regulatory reporting of events.. Work closely with R&D, Quality, Marketing, Clinical, Market Access, and other departments to align regulatory activities with business objectives.. 7+ years of experience in regulatory affairs within the medical device industry, with a focus on U.S. FDA submissions and clearances.
In collaboration with UCSF Health operational and clinical leadership, and Quality and Safety (Q/S) leadership inclusive of CQO, Vice President, Executive Directors, and Medical Directors of Adult/Pediatric services, the Director participates in setting and implementing the annual strategic priorities for patient safety. In partnership with operational leaders and key stakeholders, the Director develops strategic and operational plans to build a prospective, proactive, loss prevention, and harm reduction patient safety program that results in improved outcomes. The Department of Quality & Safety consists of Adult Quality & Safety, Benioff Children's Hospitals (BCH) Quality & Safety, Hospital Epidemiology & Infection Prevention, Regulatory Affairs, Health Equity and Clinical Documentation Integrity. Strong hospital management experience, with progressive and in-depth expertise in quality, safety and process improvement methodologies, statistical analysis, and database management.. Consistently ranked among the top 10 hospitals nationwide by U.S. News & World Report - UCSF Health is committed to providing the most rewarding work experience while delivering the best care available anywhere.
Medical Directors of Oncology Clinical Research Tanner and Associates is recruiting several Medical Directors of Oncology Clinical Research for major biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey.. Major biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join their Oncology programs.. Candidates should have an M.D. with board certification or eligibility in hematology/oncology, or a PhD, PharmD with at least 5 years of drug development experience.. Develop initial clinical designs for future trials, collaborating with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology teams, and presenting at Therapeutic Development Team meetings.. As Medical Monitor, oversee all aspects of key clinical trials in accordance with ICH/GCP guidelines.
In partnership with operational leaders and key stakeholders, the Director develops strategic and operational plans to build a prospective, proactive, loss prevention, and harm reduction patient safety program that results in improved outcomes. The Department of Quality & Safety consists of Adult Quality & Safety, Benioff Childrens Hospitals (BCH) Quality & Safety, Hospital Epidemiology & Infection Prevention, Regulatory Affairs, Health Equity and Clinical Documentation Integrity. Strong hospital management experience, with progressive and in-depth expertise in quality, safety and process improvement methodologies, statistical analysis, and database management.. Certified Professional in Healthcare Quality (CPHQ).. Safety Manager (or Director)- Heavy Civil
Staff Regulatory Affairs Specialist - Hybrid. Regulatory Affairs Manager Heart Failure (on-site). Senior Regulatory Affairs Specialist Vascular (on-site). Deputy General Counsel: Regulatory & Corporate. Regulatory Affairs Manager Vascular (on-site)
Solicits and acts on performance feedback; drives collaboration to set goals and provide open feedback and coaching to foster performance improvement.. Demonstrates continuous learning; oversees the recruitment, selection, and development of talent; ensures performance management guidelines and expectations to achieve business needs.. Bachelors degree in Business Administration, Health Care Administration, Nursing, Public Health, or related field AND Minimum eight (8) years of experience in heath care quality assurance/improvement or directly related field OR Minimum eleven (11) years of experience in heath care quality assurance/improvement or a directly related field.. Professional in Patient Safety Certificate within 24 months of hire OR Professional in Healthcare Risk Management Certificate within 24 months of hire OR Professional Healthcare Quality Certificate within 24 months of hire. Knowledge, Skills, and Abilities (KSAs): Clinical Quality Expertise; Negotiation; Business Process Improvement; Risk Management; Compliance Management; Health Care Compliance; Health Care Policy; Applied Data Analysis; Health Care Data Analytics; Learning Measurement; Consulting; Managing Diverse Relationships; Delegation; Development Planning; Agile Methodologies; Process Mapping; Project Management; Risk Assessment; Health Care Quality Standards; Quality Improvement
We're looking for an RN Patient Care Manager to join our team. You will report directly to the Executive Director, Administrator, or Senior Patient Care Manager. At least three years’ experience of direct patient care and two years’ experience in hospice or home-based care setting.. Demonstrates knowledge and compliance with accepted hospice principles and practice, including industry standards, regulations, and best practices (i.e., Medicare, Medicaid, JCAHO, ACHC), company policies/procedures, and understanding ofterminally ill patients and their families.. Company: Heartland Hospice