- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate,… more
- Solina (Bolingbrook, IL)
- …through our customers culinary vision making "Food Matter." SUMMARY OF POSITION The Regulatory Specialist assists in ensuring products meet regulatory ... ingredient statements and nutritional data to meet customer and regulatory requirements. Maintains accurate ingredient information in necessary databases and… more
- Globus Medical (Audubon, PA)
- …can resume their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes Performs routine maintenance of… more
- Barghausen Consulting Engineers, Inc. (Kent, WA)
- We are looking for a Permitting & Regulatory Compliance Specialist II to join our growing team in Kent, WA. Pay is DOE: $35-$40/hr *The pay range offered to the ... We offer tuition reimbursement to support your learning journey. Permitting & Regulatory Compliance Specialist II Job Responsibilities: Understand fuel design… more
- Envista (Brea, CA)
- Job Description: The Regulatory Affairs Specialist is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory ... Certificate of Foreign Government and Certificates of Free Sale Resolve regulatory issues and ensure companywide compliance. Reviews regulatory publications… more
- Cedent (Boston, MA)
- As a Clinical Trial Regulatory Affairs Specialist , you will be responsible for: * Regulatory Compliance: Ensuring all clinical trials adhere to applicable ... EMA, and ICH standards *Documentation Management: Preparing, reviewing, and submitting regulatory documents, such as Investigational New Drug (IND) applications and… more
- EPM Scientific (Philadelphia, PA)
- …in the ophthalmic medical device industry, is seeking an experienced and driven Regulatory Affairs Specialist to join their team in Pennsylvania. This position ... regulatory strategy and supporting innovative product development. The Regulatory Affairs Specialist should have the following qualifications: Bachelor's… more
- System One Holdings, LLC (Cranbury, NJ)
- Job Title : Food Safety & Regulatory Compliance Specialist Location : Cranbury, NJ Hours / Schedule: Monday - Friday, 8am - 4pm, onsite Type: Direct Hire ... Responsibilities The Food Safety & Regulatory Compliance Specialist is responsible for managing and coordinating food safety and quality systems while ensuring… more
- Cleerly (Denver, CO)
- …be listed as requirements in the job description. About the Opportunity As Principal Regulatory Affairs Specialist , you will provide regulatory support and ... documents. Excellent organizational, writing and verbal communication skills. Principal Regulatory Affairs Specialist (Specific) Experience: Minimum 3 years'… more
- Boston Scientific (Irvine, CA)
- …Urology solutions. We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active ... implantable device portfolio. This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product… more
- CorDx (San Diego, CA)
- …of the most critical questions in healthcare. Job Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary Range: ... $90,000 - $95,000 Position Summary: The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This ... days per week) based in Marlborough, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional… more
- Intuitive (Sunnyvale, CA)
- …(PLE) and other cross-functional supporting teams, make sure the company's regulatory affairs activities are conducted accurately, ethically based upon the latest ... relevant regulations and standards, so that regulatory compliance against China requirement is ensured for all relevant aspects throughout the lifecycle of the… more
- Cynet Systems (Piscataway, NJ)
- …to new packaging. Veeva Technical Input utilizing Veeva software to create those regulatory sections of packaging and placing them on correct panels for the copy ... sheet creation. Regulatory Formula Creation utilizing Excel to create a regulatory formula for use in global dossier documents. Qualifications: Bachelor's degree… more
- Katalyst HealthCares and Life Sciences (Pleasanton, CA)
- Responsibilities: Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and ... tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers.… more
- Cincinnati Children's (Burnet, TX)
- …protocol) and advise investigators and research coordinators regarding potential ethical, regulatory , editorial or content issues before they are submitted for full ... an informational and referral resource for the research community regarding regulatory , ethical and procedural issues. Maintain currency in field through… more
- Calyxo (Pleasanton, CA)
- …team working in a fun, diverse atmosphere. Summary: As a key member of the Regulatory Affairs team, you will play a vital role in ensuring compliance with global ... throughout the product lifecycle. You will oversee and execute post-market regulatory activities, including medical device reporting (MDR), regulatory … more
- Westchester Medical Center (Valhalla, NY)
- …in accordance with established rules, procedures, specified time frames, and regulatory requirements. The Specialist processes clinical information in a ... Job Summary : The Authorization Specialist is responsible for performing complex clerical procedures related to verifying insurance information and obtaining… more
- Vertex Pharmaceuticals Incorporated (Boston, MA)
- … Specialist supports the principles and application of quality assurance and regulatory compliance. The Specialist provides support and executes routine tasks ... related to GMP activities. Key Duties and Responsibilities: Participates in compliance related teams working towards the goal of continuous improvement. Provides QA support of change controls, GMP investigations and CAPAs. Responsible for generating… more
- Novartis (Indianapolis, IN)
- …that products are packaged accurately and efficiently. The Packaging Manufacturing Specialist adheres to regulatory requirements while performing job functions, ... of targeted radioligand therapy (RLT) to cancer patients. As a Packaging Manufacturing Specialist , you will play an active role in daily production of Radioligand… more
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