Senior Regulatory Affairs Associate
$15,000–$15,000 year
On-siteElgin, Illinois, United States
Elgin, Illinois, United StatesOn-siteFull Time$15,000–$15,000 yearSenior LevelBachelors DegreeMedium
Full TimeSenior LevelBachelors DegreeMedium
Job Summary
Ensure compliance with FDA, Health Canada, EU, and ISO standards by managing device history records, quality systems, and sterilization practices. Lead internal audits and represent the company in customer and technical file audits while supporting the department director with regulatory document submissions and inspections. Manage complaint documentation and CAPA programs to maintain alignment with emerging industry standards. Collaborate with subject matter experts to update policies and procedures. Contribute to a safe work environment by adhering to OSHA and Northgate policies.
Required Qualifications
- Bachelor's degree in health science or related field
- 5-7 years' experience in a Regulatory Affairs position
- Prior experience in the medical device and/or pharmaceutical industry
- Strong knowledge of ISO 13485:2016
- Familiar with gamma and EO sterilization process and standards
- Strong working knowledge of Microsoft Office
- Knowledge of Microsoft Dynamics GP
- Excellent written and verbal communication skills
- Solid organizational skills including attention to detail and multi-tasking skills
- Strong knowledge of FDA, Heath Canada and European Union regulations and directives
- Minimum travel, as needed
Desired Qualifications
- Regulatory Affairs Certificate an asset
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