Our client, a well-known Chicago area manufacturer of Surgical/Urology Equipment/Disposables seeks a Regulatory Affairs Specialist.
The position 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.
- Manages the documentation and evaluation of complaint information for reportability and accordance with applicable reporting requirements and analyzes compliant data for trends.
- Ensures examination and approval of device history records.
- Represents company as a lead auditor for customer, ISO and Technical File audits.
- Manages the company’s internal audit program.
- Collaborates with the Director of Quality and Regulatory to maintain the company Corrective and Preventive Action (CAPA) program.
- Ensures participation in Risk Analysis, Quality and CAPA meetings.
- Collaborates with subject matter experts to ensure that company’s policies, procedures, and practices are compliant with applicable regulatory requirements as well as current and emerging industry standards / best practices.
- Supports the Regulatory Affairs Manager with development and submission of regulatory documents, correspondence, reports, etc.; participates in regulatory inspections; and ensures company maintains awareness of regulatory changes.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in Life Science or Engineering.
- Regulatory Affairs Certificate an asset.
- 2-3 years’ experience in a Regulatory Affairs position.
- Prior experience in the medical device and/or pharmaceutical industry.
SPECIALIED SKILL OR 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, Health Canada and European Union regulations and directives.