Job Description: We are seeking an experienced Project Manager with a strong background in medical device standards (ISO 13485) and EU MDR compliance to join a cross-functional engineering environment. This role demands strong leadership, ...
Responsibilities: Defines scope of quality control activities with the document author and the required source documents and data required. Conducts independent quality control review of documents per applicable checklist by checking aga...
Job Description: Data Science and Analytics is an ambitious team of Data Scientists and Data Engineers with a unique blend of Business, Scientific, and Machine Learning expertise that seeks to unleash the full potential of Client's data a...
Job Description: We are seeking a highly organized and adaptable professional to support our medical device development and quality operations. This role is ideal for a jack of all trades. someone who enjoys creating order, connecting cr...
Roles & Responsibilities: Project to backlog CAPA and NC, Complaints. Drive to closure. NC investigations. Project Manage, cross functional exp with teams. Mechanical engineer degree preferred. Exp with regulated industry. Med device p...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required), and to ensure timely and accurate programming and validation activities f...
Job Description: Lead cross-functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, a...
Roles & Responsibilities: This position will work as an interface between the supplier and Customer plant sourcing, supplier quality and inspection areas. Conduct PPAP planning with Suppliers as per CQP. Follow up, expedition to meet de...
Responsibilities: Support preparation, review, and submission of CMC sections for U.S and global regulatory filings (INDs/CTAs, amendments, and BLAs/MAAs). Coordinate with internal stakeholders to gather technical information and ensure ...