Senior Regulatory Standards And Tests Specialist
Arjo Houghton Regis, England, United Kingdom
Job type: Full-time, Permanent
Overview
Role focused on identification, monitoring, and interpretation of global product compliance standards and regulations; driving change control processes and regulatory impact assessments; contributing regulatory input to projects and strategies.
Main Responsibilities
* Identify, monitor, and interpret global product compliance standards/regulations; facilitate change control processes and drive communication and knowledge exchange regarding impact assessment; provide input to projects with regulatory strategies.
* Participate in product and corporate development projects, executing regulatory strategies to support business goals.
* Represent the Regulatory Affairs department in project meetings, providing regulatory guidance to ensure adherence to global requirements.
* Identify, monitor, and interpret new and revised standards/regulations; maintain procedures for monitoring standards/regulations and facilitate impact assessments.
* Drive communication forums for impact assessments and manage the TrackWise process for new/revised standards; coordinate gap analyses and provide certification strategy input for testing in test agencies.
* Assist in regulatory agency audits, update departmental procedures and participate in improvement projects.
* Act as member of the PRRC group with responsibility for ensuring Technical Files are established and approve EU Declarations of Conformity (DoCs); issue statements for investigational devices used in Clinical Investigations per EU MDR.
Required Knowledge/Skills/Experience
* Experience of working with international medical device regulations and registrations.
* Knowledge of coordination with test agencies and surveillance of certifications.
* Ability to synthesize technical information in standards and convert them into information understandable for R&D and licence application documents.
* Computer knowledge in Microsoft Word and Excel.
* Excellent written and verbal communication skills in English.
Personal Qualities
* Ability to synthesize complex information and coordinate cross-functional teams.
* Ability to render clear and accurate judgments and manage projects systematically.
Contact and application
If you have any questions please contact recruiting manager David Moynham, Senior Regulatory Compliance Manager, at david.moynham@arjo.com.
Last day to submit your application is September 30, 2025.
About Arjo
At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions promote safe and dignified patient handling, medical beds, personal hygiene, disinfection, diagnostics, and prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges. For more information about Arjo visit www.arjo.com.
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