Senior Regulatory Affairs Associate

About the role

The Senior Regulatory Affairs Associate at NTI is responsible for ensuring compliance with relevant regulatory agencies and ISO standards. Key responsibilities include participating in risk analysis, quality, and CAPA meetings; collaborating with subject matter experts; supporting the development and submission of regulatory documents; and managing internal audits.

Responsibilities

• Ensures participation in Risk Analysis, Quality and CAPA meetings
• Collaborates with subject matter experts to ensure compliance with regulatory requirements and industry standards
• Supports the Director with development and submission of regulatory documents, correspondence, reports, etc.
• Participates in regulatory inspections and ensures NTI stays informed of regulatory changes
• Represents NTI as Lead auditor for customer, ISO, and Technical File audits
• Manages the company's internal audit program
• Manages Device History Records
• Manages the Quality System and the Quality Manual of the company
• Manages product sterilization requirements, practices, and records
• Ensures compliance with federal, state, and local medical affairs requirements and MDD

Requirements

Minimum required education and experience includes a bachelor’s degree in health science or related field, and 5-7 years of experience in a Regulatory Affairs position, preferably in the medical device and/or pharmaceutical industry.

Preferred qualifications include a Regulatory Affairs Certificate and strong knowledge of ISO 13485:2016, gamma and EO sterilization processes, and Microsoft Office. Excellent written and verbal communication skills, strong organizational skills, and attention to detail are also essential.

Skills & Specialized Knowledge

• Strong knowledge of ISO 13485:2016
• Familiarity 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

Benefits

Medical, Dental, Vision and Prescription Coverage
Paid Time Off
401k Retirement Plan with company match
Short- and Long-Term Disability Insurance
Life Insurance
Paid Parental Leave
Tuition Reimbursement

Pay

Competitive compensation

Schedule

Full-time, Onsite - Elgin, IL