Regulatory Intelligence Manager

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.

• 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 3^rd 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.

• 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 9001, 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

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.