Senior Regulatory Affairs Associate

At NTI, we are passionate about innovation and improving minimally invasive surgery. Since 1984, we’ve taken part in advancing laparoscopic surgical techniques by offering a growing portfolio of innovative, reliable and easy-to-use products and services. This passion has earned us recognition! NTI received the 2024 and 2023 Edison Award, which honors the best in innovation and innovators and the 2023 and 2022 Innovation of the Year Award from the Society of Laparoscopic & Robotic Surgery. We know we can’t do any of it without our talented employees! Our corporate culture revolves around our five core values: respect, trust, integrity, duty and innovation which we live and breathe every day! We are always grateful to have accomplished team members join us and help us strengthen our values. We offer competitive compensation, a strong benefits package, including paid time off and 401k with company match. NTI places high importance on the alignment of an individual’s experience with our business goals and initiatives. Join our growing company! 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 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 No Relocation Assistance Job Type: Full-time Work Location: In person/Onsite - Elgin, IL Northgate Technologies, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. As part of our recruitment process, we may use AI tools to screen applicants and assist in evaluating candidate qualifications. All final hiring decisions are made by our recruitment team. Thank you for your interest in NTI. #J-18808-Ljbffr