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.

• 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
• 2+ 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, 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.

Please review our benefits here: Life at OSI

Pay may range from $75,000 to $80,000 annually

The pay range above represents annual base salary only.  Final compensation will be determined based on factors such as your job level, geographic location, date of hire, experience, job-related knowledge and skills, and education in conjunction with market and business considerations.

Base salary is one component of your total rewards package.  You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP).  OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits.  In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty.  Full-Time salaried employees are entitled to flexible time-off.

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.