- Kelly Services (Mahwah, NJ)
- …document related changes in accordance with change management procedures and relevant regulatory requirements for medical devices . This role will ... management systems preferred. + Basic knowledge and understanding of US and International Medical Device Regulations. + Ability to plan, organize, and implement… more
- Bristol Myers Squibb (Madison, NJ)
- …objectives + Work as part of cross-functional teams-including clinical development, medical affairs, regulatory , and biostatistics-to ensure HEOR contributions ... including data model specifications, project plans, user acceptance testing scripts, device screenshots, site user guides and training slides, and data migration… more
- Integra LifeSciences (Plainsboro, NJ)
- …Expertise in one or more of the following areas: + Manufacturing of medical devices , pharmaceutical API, or drug products, Facilities, Engineering, Laboratories, ... + Strong knowledge of auditing techniques. + Minimum of 3-5 years of Medical Device , Pharmaceutical or related experience, preferably in FDA regulated industry.… more
- Organon & Co. (Jersey City, NJ)
- …project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on ... Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role...CMC with demonstrated understanding of related pharmaceutical, biological or device operations (eg, manufacturing, process development, analytical, and quality… more
- United Therapeutics (Trenton, NJ)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- Edgewell Personal Care (Allendale, NJ)
- …for assessing, interpreting, and following global regulations for OTC drugs, medical devices , cosmetics, biocides and consumer goods. Ensures standards ... across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the...OTC drug regulations for FDA, Health Canada, and TGA. Medical devices 's regulations in the USA, Canada,… 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)
- …officials in regards to the storage and distribution of any drug products, medical devices , food products, dietary supplements, general products, and biocides as ... experience in manufacturing and or distribution of pharmaceutical products, medical devices or food industry in a...development and manufacturing in the consumer goods, pharmaceutical, or medical device industries. + Must have experience… more
- Fujifilm (Trenton, NJ)
- …II + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and other Key Operators in the use of Fujifilm's Medical Informatics. The Senior Clinical Consultant, MI - I...business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties… more
- Fujifilm (Wayne, NJ)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... but will consider applicants with repair experience in electronics, medical device , mechanical, or a similar field....handle or feel objects, use electronic or mechanical repair devices , fine motor skill dexterity, reach with hands and… more