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Rapiscan Systems · 2 days ago

Regulatory Affairs Specialist

Billerica, MA

Full-time

Onsite

Senior Level

6+ years exp

Rapiscan Systems, an OSI Systems Company, is seeking a Regulatory Affairs Specialist to support global regulatory compliance for their security screening products. The role involves ensuring products meet regulatory requirements across international markets and collaborating with various teams to integrate these requirements into product development.

Cyber SecurityGovernmentInformation TechnologySecuritySoftwareVirtual Reality

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 company’s core values of Integrity, Innovation, Accountability, and Teamwork

Demonstrate behavior consistent with the company’s 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

Qualification

Regulatory Affairs ExperienceInternational Regulatory FrameworksRegulatory SubmissionsRegulatory Software ProficiencyProject ManagementCommunication SkillsOrganizational Skills

Required

Bachelor's degree or equivalent in a scientific, engineering, or regulatory discipline

6+ years of experience in regulatory affairs, preferably in security technology, regulated products, or a related field

Knowledge and experience working with international regulatory frameworks (e.g., SAFETY Act, EU Directives, TSA, ISO 9001, ISO 14001, ISO 45001, IEC standards)

Strong organizational and communication skills with demonstrated ability to communicate requirements to cross-functional team members

Ability to manage multiple projects and deadlines in a fast-paced environment