- Abbott (Santa Clara, CA)
- …communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance . Premarket: Assess the acceptability of quality, ... Abbott is a global healthcare leader that helps people live more fully...software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite… more
- Experis (St. Paul, MN)
- …a Regulatory Affairs Specialist , you will be part of the regulatory affairs team supporting global healthcare initiatives. The ideal candidate will have ... Our client, a global leader in medical device manufacturing , is seeking a Regulatory Affairs Specialist to join their team, fully remote , reporting to… more
- Conmed (Denver, CO)
- … Affairs Specialist plays a critical role in ensuring regulatory compliance and supporting cross-functional teams in the preparation, submission, ... coming changes, facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Stay current with health authority… more
- Boston Scientific (Maple Grove, MN)
- …pipeline, and we will continue to make an investment in Interventional treatments. This Regulatory Affairs Specialist II role will be a part of the ... devices. In this role you will participate in activities to ensure compliance with worldwide regulatory requirements. Your responsibilities include: Acts as… more
- Boston Scientific (Marlborough, MA)
- …responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering ... Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations. Interact with regulatory agencies as… more
- Intuitive (Sunnyvale, CA)
- …[Sr. Regulatory Engineer] or in a Science field (preferable) [Sr. Regulatory Specialist ] Experience: Minimum 5 years relevant experience working in a ... teams around the world to help solve some of healthcare 's hardest challenges and advance what is possible. Intuitive...of clinical strategy and design inputs and outputs on regulatory filings and compliance . Create awareness within… more
- Merck & Co. (Durham, NC)
- …Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product activities ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Boston Scientific (Maple Grove, MN)
- …applications and post-market studies Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings ... risk and pain. This role provides opportunity to gain regulatory experience in US, China, Japan, and other international...comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you… more
- BioTalent (Westlake Village, CA)
- Senior Regulatory Specialist In your role as a Sr. Regulatory Specialist , you will develop and implement medical device regulatory strategies to ... and provide regulatory input and guidance to cross-functional partners for regulatory documentation for medical device approvals in compliance with EU MDR,… more
- Eisai, Inc (Nutley, NJ)
- …sales/business analytics) preferred.Experience working with pharmaceutical manufacturer compliance & regulatory requirements preferred.Experience navigating ... Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is...Alzheimer's disease (AD) or mild AD. The Neurology Account Specialist (NAS) will be part of a diverse team… more
- Globus Medical (Audubon, PA)
- …needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes Performs routine maintenance ... the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture...their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting… more
- Merck & Co. (Rahway, NJ)
- …Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance , Reviewing Literature {+ 4 more}-Preferred ... Job DescriptionTitle: Specialist , Metrology and Validation, Analytical Research & DevelopmentJob Description-The Analytical Research & Development (AR&D) External… more
- Merck & Co. (Boston, MA)
- …accelerating research and innovation.- We are seeking a passionate and knowledgeable Senior Specialist to join our Library team.- In this position, you will be ... linking our stakeholders with scientific and medical information resources. A successful Senior Specialist will have a drive for mastering a wide range of databases… more
- Eisai, Inc (Raleigh, NC)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... profile, we want to hear from you. The QA Specialist plays a critical role in ensuring the quality...plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the… more
- Eisai, Inc (Phoenix, AZ)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Merck & Co. (Omaha, NE)
- …time. -We are seeking a Growth and Improvement minded Associate Specialist , Logistics who can help drive our Strategic Operating Priorities.Strategic SummaryThe ... Associate Logistics Specialist will be responsible for export of raw materials...closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so… more
- Kaiser Permanente (Pleasanton, CA)
- Job Summary: Conducts regulatory audits and surveys by independently reporting and keeping current on regulatory requirements in preparation for surveys. ... content and delivers education programs to align policies with regulatory requirements. Conducts data management by entering and analyzing practitioner/provider… more
- Merck & Co. (Rahway, NJ)
- …Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication skillsets ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Hackensack Meridian Health (Hackensack, NJ)
- …healthcare and serve as a leader of positive change. The Physician Practice Compliance Specialist is responsible for assuring on-going compliance by ... New Jersey. Responsibilities A day in the life of a Physician Practice Compliance Specialist at Hackensack Meridian Health includes: Performs retrospective and… more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of an interdisciplinary team… more
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