Senior Regulatory Affairs Associate

Trudell Medical Group•Elgin, IL

4d•Onsite

About The Position

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!

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; and 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 and 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