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.
- Understanding and knowledge of the format and content of regulatory submissions and/or registration documents and associated registration processes
- Hands 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 knowledge
- Scientific Knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- strong oral and written communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
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.
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