"Alerted.org

Job Description:

North Star Imaging (NSI), a global leader in 2D digital radiography and 3D computed tomography equipment, is part of Illinois Tool Works (ITW), a Fortune 250 company. We offer an engaging work environment with exceptional opportunities for personal and career development.

We are seeking a Regulatory Compliance Specialist whose primary role is to ensure that all industrial X-ray systems manufactured, installed and serviced by North Star Imaging comply with applicable national and international regulations, standards, and environmental health and safety requirements. In addition they will work across all divisions on regulatory research, documentation, audits, and collaboration with engineering, manufacturing, and quality teams to maintain compliance throughout the product lifecycle.

Responsibilities:

+ Monitor, interpret, and implement regulatory all environmental, health and safety standards applicable to industrial X-ray systems, including but not limited to FDA, ISO, OSHA, ATF, and state-specific radiation regulations.

+ Assist in obtaining and maintaining regulatory approvals and certifications for products.

+ Conduct compliance audits and risk assessments to ensure adherence to safety, environmental, and industry standards.

+ Develop, maintain, and update compliance documentation, including technical files, regulatory submissions, and safety reports.

+ Work closely with engineering and product development teams to ensure new products and modifications meet regulatory requirements.

+ Support training programs for employees regarding compliance policies, radiation safety, and regulatory requirements.

+ Act as a liaison with regulatory agencies, auditors, and customers regarding compliance matters.

+ Track and analyze regulatory changes and proactively recommend necessary company adaptations.

+ Assist in incident investigations, corrective actions, and non-conformance resolution related to compliance and safety issues.

+ Oversee Nadcap compliance for the Scanning Services Division, ensuring all processes and procedures meet accreditation requirements for NDT services.

Qualifications:

+ 2 years of experience minimum in regulatory compliance, preferably in medical devices, industrial equipment, or radiation-emitting devices.

+ Experience in FDA submittals regarding CFR 1020.40, ISO 9001, ATF D1.3 & D1.4, Nadcap AC7000/AC7114, NRC regulations & state specific radiation safety requirements.

+ Additional technical compliance familiarity with ASNT SNT-TC-1A, NAS 410, ASTM E sections pertaining to DR/CT are desirable.

+ Experience with regulatory submissions, product testing, and certification processes, conducting audits and being audited.

+ Strong analytical, problem-solving, and project management skills.

+ Excellent communication and technical writing abilities.

+ Ability to work collaboratively in a cross-functional team environment.

+ Certification in Regulatory Affairs (RAC) or Radiation Safety Officer (RSO) certification is a plus.

Take this opportunity to join a professional and successful team where you can make a significant impact immediately. Enjoy competitive compensation and generous benefits that includes health, dental, life and LTD insurance, paid parental leave, 401k (with match), and a generous tuition reimbursement program.

Compensation Information:

The salary for this position ranges from $85,000 to $110,000 based on education and experience.