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.

• 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.

• 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.

Preferred Skills:

• Experience with regulatory submissions for radiation-emitting devices or trace detection systems.
• Familiarity with cybersecurity regulations and export control compliance.
• Proficiency in regulatory software tools and document control systems.

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Please review our benefits here: Life at OSI

The specific programs and options available to any given employee may vary depending

on eligibility factors such as geographic location and date of hire. Please note that the salary information shown above is a general guideline only. Salaries are based upon candidate experience and qualifications, as well as market and business considerations.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively "OSI") does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer - Disability and Veteran Know Your Rights

Poster Link:

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and

inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.