Regulatory Affairs Lead - Medical Devices Submissions
Colgate Palmolive
Colgate-Palmolive is hiring a Regulatory Affairs Project Manager in Piscataway, NJ to lead complex regulatory submissions and ensure strict QMS/GMP compliance. You will drive cross-functional collaboration, manage risks, and advance the company’s 2030 regulatory objectives for medical devices and Rx drug innovations. The role emphasizes continuous improvement, stakeholder reporting, and training, with a focus on North American commercialization timelines and global regulatory activities. #J-18808-Ljbffr Colgate Palmolive
- Colgate-Palmolive is seeking a Regulatory Affairs Project Manager in Piscataway, NJ to lead global regulatory submissions (FDA/Health Canada) and oversee QMS improvements for medical device and Rx portfolios. You will drive cross-functional programs, manage risk, and accelerate...Medical device
- Stark Pharma is looking for a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices and pharmaceuticals. You will prepare and... ...documentation, maintain compliance, and assist with FDA submissions to ensure adherence to regulatory standards....Medical device
- Role: Regulatory Affairs Associate Location: United States Duration: Long Term contract Position... ...to support regulatory activities for medical devices, pharmaceuticals, biotechnology... ...will assist in preparing regulatory submissions, maintaining regulatory documentation...Medical deviceLong term contract
- Eurofins Scientific is seeking a Sample Extraction Manager for Medical Device studies in South Brunswick, NJ. You will oversee... ...instructions, and maintaining accurate documentation to support regulatory submissions. Excellent leadership and communication are essential. #J...Medical device
- Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent.... .... Job Description Description: The Regulatory Affairs Associate, with minimal guidance prepares... ...documents for annual report submissions. Archive and maintain all post approval...Medical device
$26 - $35 per hour
...NJ to oversee the manufacturing process. This role requires leading batch production and adhering to cGMP standards while ensuring... ...3 years of manufacturing experience in the pharmaceutical or medical device fields, along with a high school diploma or GED. Amneal offers...Medical deviceHourly payShift work- ...Description Job Description Roles & Responsibilities: Lead and manage Computer System Validation (CSV) activities across... ...experience in CSV / Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences. ~ Strong knowledge of GxP validation...Medical device
- ...plans, and eCRF testing, while coordinating with vendors and cross-functional partners to meet regulatory standards. Ideal candidates have extensive CDM experience in medical device programs, strong GCP/ICH/FDA knowledge, and a track record of delivering data quality and...Medical device
- ...Description Job Description Summary: Our client is a leading medical device company and is seeking an experienced CAPA Program Lead to... ...quality remediation initiative supporting medical device regulatory compliance. This consultant will assess existing quality...Medical device
$26 - $35 per hour
Description: The Group Leader is responsible for leading the manufacturing process of batches. In addition, the Group Leader will... ...or more in Manufacturing experience in the Pharmaceutical or Medical Device industry. This position requires successful completion of an...Medical deviceHourly payTemporary workLocal areaFlexible hoursDay shift- ...in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the... ...solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project... ...Medical Device Safety team members. Lead assigned safety projects and...Medical deviceRemote work
- ...****@*****.*** We are seeking a distinguished Lead SAP GTS Consultant to serve as the Global... ...experience, understanding the unique regulatory and compliance requirements within the pharmaceutical, biotech, or medical device sectors. Team Leadership: Prior Team Leading...Medical deviceFull time
$178k - $307.05k
...for a Sr. Director, Regulatory Law, Orthopedics located... ...the orthopedic medical device and technology portfolio... ...closely with Regulatory Affairs, Quality, R&D, and... ...counsel on regulatory submissions, product clearances and... ...or approval. Lead regulatory legal risk...Medical deviceLocal areaImmediate start$124k - $160k
...healthier future for all. Title: Regulatory Affairs Project Manager Location:... ...Project Manager, you will lead the planning, execution, and... ...of complex global regulatory submissions and ensure the rigorous maintenance of our Medical Device Quality Management System (QMS...Medical deviceHourly payLocal areaRelocation package$122k - $212.75k
...Description The Senior Manager, MedTech SCT Surgery Plan Leader, leads the Surgery Planning technology portfolio across demand,... ...or related discipline. Preferred Related Industry Experience: Medical device, life sciences, or other regulated global supply chain environment...Medical deviceTemporary workWork at officeLocal areaImmediate start- ...New Brunswick, NJ is recruiting a Senior Procurement Manager to lead Electrophysiology and Neurovascular supplier strategies and... ...0M in spend, requires 8+ years in procurement with a focus on medical device supply chains, and offers leadership of a cross‑functional team...Medical device
- ...Tech in New Brunswick, NJ, seeks a Senior Procurement Manager to lead procurement activities for Electrophysiology and Neurovascular... ...leadership skills, and a track record in regulated manufacturing. #J-18808-Ljbffr 6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal EntityMedical device
- ...Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/... ...Experience with medical devices / healthcare regulatory affairs. Knowledge of U.S. and OUS device regulations...Medical device
- ...of Advertising & Promotions to join the Regulatory Affairs team. The role provides senior... ...Advertising and Promotion, the incumbent will lead complex promotional reviews, advise on substantiation for claims, manage FDA submission #J-18808-Ljbffr Tris Pharma, Inc
- Johnson & Johnson MedTech is recruiting for a Project Lead, R&D Partnerships in MedTech, to lead external... ...functional teams. The role focuses on delivering complex medical devices from concept to market, with regulatory obligations and a flexible hybrid work arrangement...Medical deviceFlexible hours
- ...validation project Experience in the Pharmaceutical, Biotechnology, or Medical Device industry - 5+ years in System Development Lifecycle 5+ years'... ...skills Ability to work collaboratively in teams, lead projects, or work independently Experience working with remote...Medical deviceRemote work
$184.24k - $276.36k
Director, Regulatory Affairs, Companion DiagnosticsLanguage View... ...tests and other devices to enhance the value... ...development and CDx submission plan for each country... ...trial protocols and medical device protocols) ICF... ...collaboration with CDx lead work with Dx partners...Medical deviceLocal area- ...Job Description: Regulatory Affairs Senior Associate The purpose... ...facilitating timely and complete submissions Develop up-to-date... ...complexity Experience leading end-to-end regulatory... ...framework for OTC drugs, OTC medical devices Ability to ensure...Medical device
- ...Position - Lead Architect — Enterprise Ansible Automation (CIQ Ascender) & Chef Migration Location - Raritan, NJ Duration... ...Preferred Qualifications Experience in pharmaceutical, medical device or other regulated industries (GxP, CSV, 21 CFR Part 11, SOX)....Medical deviceFull timeLive in2 days per week3 days per week
$140k - $160k
...Description Job Summary The Regulatory Affairs Strategist is responsible... ...while facilitating timely submissions for clinical trials,... ...jurisdictions where applicable. Lead and manage responses to... ...experience—pharma, biotech, or medical devices. ~ Deep knowledge of FDA...Medical deviceLocal area- ...seeking an experienced Operations Manager to lead day-to-day operations for a growing... ...compliance with applicable quality and regulatory requirements • Support capacity... ...• Experience in aerospace, defense, medical devices, electronics, or a similar industry is...Medical device
$53.03 - $56.81 per hour
...- 56.81/hr. Role: Siemens Polarion Lead Product Analyst Job Description :... ...contractor will partner with R&D, quality, regulatory, systems engineering, and technology... ...Five or more years of experience in the medical device or another regulated industry. Hands...Medical deviceContract workFor contractors- ...seeking a Scientist II in New Jersey to support drug product development for regulatory filing. You will lead bench development activities, ensure cGMP compliance, and contribute to ANDA submissions with thorough documentation. The role emphasizes hands-on formulation work...
- ...Pharma Solutions Inc. is seeking a Medical Reviewer to assess medical device safety cases, adverse events, and deficiencies... .... You will review data, ensure regulatory compliance, and collaborate with... .... The candidate will mentor staff, lead safety projects, and coordinate...Medical deviceRemote job
- SmartRecruiters, Inc. is seeking a QA/compliance-focused Laboratory Specialist in New Jersey to manage quality complaints from the call center. You will enter PQC data into the QA database, secure product samples, coordinate replacements or reimbursements, and perform lab...Medical device
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