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Regulatory Intelligence Manager
Regulatory Intelligence ManagerOSI Systems, Inc • Billerica, Massachusetts
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Regulatory Intelligence Manager

Regulatory Intelligence Manager

OSI Systems, Inc • Billerica, Massachusetts
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Job Description

Overview

Rapiscan, an OSI Systems Company is seeking a Regulatory Intelligence Manager, 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 Intelligence Manager is responsible for worldwide Regulatory Intelligence, including regulations and standards for product approvals and certifications, product safety, environmental protection, and occupational health & safety requirements. This position is a key role within the organization and will help to ensure new and modified regulations and standards are known, assessed, and communicated throughout Rapiscan.

The Regulatory Intelligence Manager will implement processes to ensure new and modified regulations and standards are properly monitored, analyzed, and interpreted for Rapiscan products in a timely manner. This role will be responsible for the creation of processes to proactively track regulatory changes, assess the impact, and work with key stakeholders for implementation ensuring the organization remains complaint and competitive.

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

Responsibilities

  • Establish and maintain processes for tracking, analyzing, and implementing new / modified regulatory requirements.
  • Continuously track and analyze new and updated regulations, guidelines, and industry standards across various jurisdictions.
  • Evaluate how regulatory changes affect Rapiscan’s operations, products, services, and overall business strategy.
  • Provide insights and recommendations to key stakeholders on how to adapt to regulatory changes and develop effective compliance strategies.
  • Monitor the organization to support adherence to all applicable regulations
  • Effectively communicate regulatory intelligence updates to stakeholders
  • Create and deliver training on regulatory topics to educate employees and ensure a strong understanding of compliance requirements.
  • Keep abreast of emerging trends, best practices, and technological advancements in regulatory intelligence.
  • Develop KPIs / metrics on Rapiscan’s performance to adherence to new / modified Regulatory requirements
  • Develop and maintain a regulatory database for finished products and raw materials
  • Manage 3rd party Supply Chain Data Management provider
  • 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.

Qualifications

  • Regulatory Knowledge
  • Bachelor’s degree or equivalent in a scientific, engineering, or regulatory discipline
  • 8+ years of experience in regulatory affairs, with a strong understanding of relevant regulations, guidelines and industry standards, preferably in security technology, regulated products, or a related field
  • Knowledge and experience working with international regulatory frameworks (e.g., FDA, CE, TSA, ISO , IEC standards, REACH, RoHS, PFAS, etc.).
  • The ability to critically analyze complex information, identify key trends, and assess the impact of regulatory changes.
  • Excellent written and verbal communication skills to effectively convey regulatory information to diverse audiences.
  • Proven ability to manage projects, prioritize tasks, and meet deadlines in a fast-paced environment.
  • The capacity to build and maintain strong relationships with internal and external stakeholders.
  • Familiarity with regulatory technology solutions, supply chain data management solutions, data analytics tools, and emerging technologies.
  • #LI-JL1

    Preferred Skills :

  • Experience with worldwide regulations for radiation-emitting devices, trace detection systems, environmental, health and safety requirements.
  • Familiarity with cybersecurity regulations and export control compliance
  • Proficient in regulatory software tools, databases, and document control systems
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    Regulatory Manager • Billerica, Massachusetts

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