- Integra LifeSciences (Princeton, NJ)
- …possess and demonstrate an understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Regulation, Canadian Medical Device Regulations, ... specialist position provides support across multiple functional areas, including regulatory intelligence, device establishment registration and listing (FURLS),… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and other international requirements and submissions. + Knowledge of product development and medical device quality system regulations. + Experience with ... EU, and other global regulatory requirements are met. + Evaluates medical device regulations and leads development of global regulatory strategies to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …education and experience. + Preferred minimum of ten-to-fifteen years of experience in the medical device industry, with at least nine years in a regulatory ... self. Become a **maker of possible** with us. The Regulatory Affairs (RA) Director is responsible for the management...legal); and negotiate with Regulators. + Ability to interpret medical device testing methods and statistics, as… more
- Organon & Co. (Jersey City, NJ)
- … CMC scientists in the Organon franchise teams. + Enable implementation of regulatory CMC strategies to ensure high quality , accuracy, and high likelihood ... appropriate reviews, approvals and systems are in place to maintain the quality of scientific, technical and regulatory information within CMC submissions,… more
- Organon & Co. (Jersey City, NJ)
- …or device operations (eg, manufacturing, process development, analytical, and quality assurance) is required. + At least five years of relevant experience, ... project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Sanofi Group (Morristown, NJ)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge,...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Integra LifeSciences (Plainsboro, NJ)
- …+ Strong knowledge of auditing techniques. + Minimum of 3-5 years of Medical Device , Pharmaceutical or related experience, preferably in FDA regulated industry. ... patient outcomes and set new standards of care. The **Internal Auditor, Regulatory Compliance** will have an in-depth understanding and knowledge of appropriate GMP… more
- Integra LifeSciences (Plainsboro, NJ)
- …13485, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. The QA Engineer II ... (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Interact and coordinate activities with...Experience: 3 to 6 years of experience in a Quality Assurance role for medical device… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …or equivalent (Preferred) + Minimum 10 years of experience work experience in the Quality organization of a Medical Device and/or pharmaceutical company. ... program. In this role, she/he is responsible for implementing quality and regulatory audits of BD facilities... Audits to assure compliance with domestic and international medical device standards and regulations, local procedures,… more