Senior Regulatory Standards And Tests Specialist

Job type: Full time, Permanent

Main responsibilities

Responsible for identification, monitoring, and interpretation of global product compliance standards/regulations. Facilitate and drive the change control process for standards/regulations and drive communication and knowledge exchange regarding impact assessment. Provide input to projects with regulatory strategies.     

Regulatory Affairs Doer and Lead:

• Participate in product and corporate development projects, executing regulatory strategies to support business goals.
• Represent the RA department in project meetings, providing regulatory guidance to ensure adherence to global requirements.

Standards and Regulations:

• Identify, monitor, and interpret new and revised standards/regulations.
• Maintain procedures for monitoring standards/regulations and facilitate impact assessments.

Communication and Coordination:

• 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.

Audits, QMS & CAPAs:

• Assists in regulatory agency audits, updates of departmental procedures and participate in improvement projects.

Person Responsible for Regulatory Compliance (PRRC):

• 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 referred to in EU MDR Section 4.1 of Chapter II of Annex XV.

Required Knowledge/Skills/Experience

• Experience of working with international medical device regulations and registration.
• Knowledge of coordination with test agencies and surveillance of certifications.
• Must be able to synthesize technical information in standards and convert them into information understandable language for R&D and licence application documents.
• Computer knowledge in Microsoft Word and Excel.
• Excellent written and verbal communication skills in English.

Personal Qualities:

• Must have the ability to synthesize complex information.
• Ability to coordinate, facilitate and work well on cross-functional teams.
• Must be able to render clear and accurate judgements.
• Must be able to manage projects systematically.

Contact and application:

If you have any questions please contact recruiting manager David Moynham, Senior Regulatory Compliance Manager on david.moynham@arjo.com.

Last day to submit your application is on September 30th 2025.