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Regulatory Intelligence

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Regulatory Intelligence

Job Summary:

The RA Specialist – Regulatory Intelligence is responsible for the assessment of the applicability of documents of external origin (i.e., standards, regulations) and maintenance of procedures associated with regulatory intelligence (RI). The RA Specialist – Regulatory Intelligence is responsible for leading and coordinating RI, proactive global monitoring, the firm connection with the Documents of External Origin (DOEO) process, and the communication/dissemination of RI information to the wider organization.

Essential Functions & Accountabilities:

The discovery, analysis, assimilation, and communication of regulatory intelligence as input to the DOEO process. This involves keeping abreast of relevant regulatory developments, ensuring organisational readiness, and advocating for positive regulatory reform. This includes monitoring USFDA, Health Canada, ANVISA, EU European Medicines Agency, UKCA and MHRA, MedDO and Swissmedic, TGA, PMDA, NMPA, and other agency regulations and DOEO. This includes the International Medical Device Regulators Forum (IMDRF), Working Groups, Technical Committees, external conference/training attended by professional committees (i.e., Regulatory Affairs Professional Society) or sponsored by various Ministries of Health (MoH), direct MoH communications to manufacturers and external regulatory intelligence databases such as British Standards Institute Compliance Navigator or MedTech, new/revised DOEOs such as ISO standards, and other relevant technical standards.
Apply an understanding of the underlying science as it relates to RI, for contact lens and contact lens care products.
Actively develop an understanding of health authority inner workings, regulatory requirements, and potential interpretation of regulatory guidelines.
Collect regional regulatory intelligence and provide monthly reports. Monitor impact of changing regulations on submission strategies and notify appropriate departmental personnel.
Apply an understanding and working knowledge of the key global regulatory agencies.
Maintain regulatory files and documents in addition to internal regulatory tracking documents. This includes maintaining communication with supervisor and other departments to provide status reports.
Assess applicability of DOEO (i.e., standards, regulations) and maintain procedures associated with this process, including RI.
Respond to corporate inquiries and follow up to internal processes (i.e., Regulatory Affairs Impact Documents (RAIDs), RA database, RI).
Follow regulatory plans and interface with project team members, both within the organisation and with a range of external groups, to drive corporate regulatory initiatives to completion. Liaise with internal functions such as quality assurance (QA) Operations, Operations, Manufacturing, Professional Services, Legal, RA, and Marketing to provide necessary information and documentation requested.
Develop and maintain RI process and other regulatory/quality systems processes as needed.
Develop familiarity with the database-oriented software, regulatory information management (RIM) system, Agile PLM (product lifecycle management)/global RA database reporting functions reporting key performance indicators (KPIs) and roll out plans to global RA team and management (metrics analysis and reporting).
Generate a meaningful output of RI by translating learnings to educate the business about RI and how it impacts the business. Ability to prepare and publish regulatory intelligence newsletter and presentations. Take the lead in delivering the regulatory newsletter content to the organisation, as well as ownership of the content and updates to RI globally.
Perform quality checks of global regulatory requirements and documents for appropriate categorisation, redundancies, errors, and documents that are out of scope.
Lead the development and refinement of RI processes and procedures to build efficiencies, track minutes from related meetings, and coordinate RI review meetings.
Prepare new/revised regulatory requirements for site Management Reviews.
Prepare MDSAP Chapter 2 data to MDSAP sites in preparation for their audits.

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales

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