1 job found in bloomington, indiana

job summary: Leader in medical device manufacturing is looking for Regulatory Affairs Associate in Bloomington, IN for a contract role expected to last 12 months, possible extension, possible temp to perm. Candidate should have Bachelor's Degree or country equivalent with a minimum of 7 years in a regulated environment.   location: Bloomington, Indiana job type: Contract salary: $35.00 - 42.24 per hour work hours: 8am to 5pm education: Bachelors   responsibilities: Drive integration and transition of products into regulatory operation processes.Project team member representing Regulatory Affairs Operations, driving timelines and deliverables related to submission documents.Primary Regulatory Operations liaison to internal and external groups, including regulatory authorities on electronic submissions and documentation systems.Regularly interacts with RA management and functional peer groups inside and outside the department.Provide system and process support, development and training. Qualifications: Understanding and knowledge of the format and content of regulatory submissions and/or registration documents and associated registration processesHands on experience with electronic submissions and eCTD (INDs, BLAs. NDAs)Expert skills in electronic publishing/document/data management systems (e.g. Documentum, ISI Toolbox, eCTD Xpress and database creation/management)Sound basis of Regulatory knowledgeScientific KnowledgeAbility to manage complex projects and timelines in a matrix team environmentstrong oral and written communication and presentation skillsDemonstrated interpersonal skills including strong negotiation skills Education and/or Experience: Bachelor's Degree or country equivalent with a minimum of 7 years in a regulated environment   qualifications: Experience level: ExperiencedEducation: Bachelors  skills: Regulatory Affairs / Compliance Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.