- Chemours (Trenton, NJ)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Integra LifeSciences (Princeton, NJ)
- … Device Regulations, Japanese QMS Ordinance, Australian Therapeutic Goods ( Medical Devices ) Regulations, Brazil's Agencia Nacional de Vigil*ncia Sanitaria ... data analysis, managing data uploads and verification, and ensuring high- quality , timely support for the Global Regulatory ...understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Regulation, Canadian Medical… 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 ... Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing...global regulatory requirements are met. + Evaluates medical device regulations and leads development of… 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 ... of United States, European, and international regulations and standards covering medical devices . + Demonstrated organizational, planning, and program management… more
- Robert Half Technology (Mahwah, NJ)
- …management systems. * Solid understanding of quality assurance principles and regulatory requirements for medical devices . * Experience in change ... part in managing document-related changes while ensuring compliance with regulatory standards for medical devices ....and effectiveness of documentation systems. * Support compliance with medical device regulations and quality … 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 ... regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides … more
- Sanofi Group (Morristown, NJ)
- …(3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge,...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… 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
- 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
- United Therapeutics (Trenton, NJ)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more