- 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
- 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
- Merck (Rahway, NJ)
- …product life cycle. + Oversee the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in...Affairs team plays a vital role in delivering new medical advancements to patients around the world. By facilitating… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- Reckitt (Parsippany, NJ)
- …in development and manufacturing in the consumer goods, pharmaceutical, or medical device industries. + Must have experience with quality tools such as: SPC, ... officials in regards to the storage and distribution of any drug products, medical devices , food products, dietary supplements, general products, and biocides as… more
- Merck (Rahway, NJ)
- …and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, ... leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally. + Develop and execute… more
- Sanofi Group (Morristown, NJ)
- …and bring hope to patients and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to lead the industry in ... ambition to develop, launch and maintain best-in-class drug delivery systems and connected medical devices that address patient unmet needs and improve health… more
- Merck (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies + In-depth knowledge of global regulatory requirements for medical devices and combination products and ... & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate will… more
- Integra LifeSciences (Princeton, NJ)
- …responsibilities are to: + Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, ... Device Directive, ISO 14971, IEC 60601 and other regulatory standards. + Lead the identification and resolution of...scientific discipline. + Minimum 5 years Medical Devices or Pharmaceutical experience in Quality or… 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