The
Senior Regulatory Affairs Associate is responsible for the company's compliance to the applicable regulatory agencies such as FDA (CFR's Code of Federal Regulations), Health Canada and the European Union and for compliance to the applicable ISO (International Standards Organization) standards.
Regulatory Affairs- Ensures participation in Risk Analysis, Quality and CAPA meetings
- Collaborates with subject matter experts to ensure that NTI's policies, procedures, and practices are compliant with applicable regulatory requirements as well as current and emerging industry standards / best practices
- Supports the department Director with development and submission of regulatory documents, correspondence, reports, etc.; participates in regulatory inspections; and ensures NTI maintains awareness of regulatory changes
Administration- Represents NTI as Lead auditor for customer, ISO and Technical File audits
- Manages the company's internal audit program
- Manage Device History Records
- Manage the Quality System and the Quality Manual of the company
- Manage product sterilization requirements, practices, and records
Organization- Ensures compliance of company and personnel with all Federal, State, and local requirements related to medical affairs as well as the requirements of the MDD and other applicable agencies
- Manage support personnel
Complaints and Non-Conformances- Manages the documentation and evaluation of complaint information for reportability in accordance with applicable reporting requirements and analyzes complaint data for trends
- Collaborates with the Director of Quality and Regulatory to maintain the company Corrective and Preventive Action (CAPA) program
Health and Safety- Contribute to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable
Minimum Required Education and Experience- Bachelor's degree in health science or related field
- Regulatory Affairs Certificate an asset
- 5-7 years' experience in a Regulatory Affairs position
- Prior experience in the medical device and/or pharmaceutical industry
Skills & Specialized Knowledge:- 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
Working Conditions- Clean office environment
- Minimal travel, as needed
Job Type: Full-time
Work Location: In person/Onsite - Elgin, IL
