Regulatory Affairs Specialist

Regulatory Affairs Specialist

Rapiscan, an OSI Systems Company is seeking a Regulatory Affairs Specialist based out of Billerica, MA.

Rapiscan Systems, an OSI Systems, Inc. company, designs, manufactures and markets security and inspection systems worldwide. Our products are used to inspect baggage, cargo, people, vehicles and other objects for weapons, explosives, drugs and other contraband. Rapiscan Systems security and inspection devices can be found in a wide range of locations such as airports, border crossings, railway stations, seaports and terminals, government and military installations, and nuclear facilities.

The Regulatory Affairs Specialist will support global regulatory compliance for Rapiscan Systems security screening products. This role ensures that products meet applicable regulatory requirements across international markets, including certifications, registrations, and ongoing compliance with standards / Directives such as RED Directive, Machinery Directive, EMC, TSA, CE Marking, and other regional authorities.

This position is on-site and located in Billerica, MA. Candidates at other Rapiscan locations may be considered.

Responsibilities

• Prepare and submit regulatory filings, including product registrations, certifications, and renewals.
• Support Regulatory Intelligence in interpreting global regulatory requirements and communicating changes to internal stakeholders.
• Collaborate with engineering, quality, and product management teams to ensure regulatory requirements are integrated into product development and lifecycle processes.
• Maintain regulatory documentation and databases to support audits and inspections.
• Support internal and external audits, including responses to regulatory inquiries and corrective actions.
• Liaise with regulatory bodies and agencies.
• Provide regulatory input during risk assessments and design reviews.
• Monitor post-market activity to help ensure product performance and compliance.
• Uphold the companys core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the companys Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

Preferred Skills :