Senior Regulatory Affairs Associate

Northgate Technologies•Elgin, IL

3d•Onsite

About The Position

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. This role 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. The associate 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. Additionally, the role represents NTI as Lead auditor for customer, ISO and Technical File audits, manages the company’s internal audit program, Device History Records, the Quality System and the Quality Manual, and product sterilization requirements, practices, and records. The position also 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, and manages support personnel. The associate manages the documentation and evaluation of complaint information for reportability in accordance with applicable reporting requirements and analyzes complaint data for trends, and collaborates with the Director of Quality and Regulatory to maintain the company Corrective and Preventive Action (CAPA) program. The role also contributes to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable.

Requirements

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

Nice To Haves

Regulatory Affairs Certificate an asset

Responsibilities

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
Ensures NTI maintains awareness of regulatory changes
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
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
Manages the documentation and evaluation of complaint information for reportability in accordance with applicable reporting requirements
Analyzes complaint data for trends
Collaborates with the Director of Quality and Regulatory to maintain the company Corrective and Preventive Action (CAPA) program
Contribute to a safe work environment by complying with all federal & state laws, Northgate policies, procedures and OSHA, if applicable