Regulatory Affairs Specialist – Global Life Sciences

Peopleforce Recruitment Ltd; Dundee; On-site; GBP 40,000 - 60,000; Full time

Job summary

Peopleforce Recruitment Ltd is recruiting a Regulatory Affairs Specialist for Dundee, office-based, to reinforce the Compliance Team. The role focuses on ensuring that products, processes and quality systems meet UK, EU, Swiss and international regulatory requirements.

You will work with internal stakeholders and regulators to provide regulatory expertise across registrations, vigilance, regulatory intelligence, and technical documentation, supporting quality systems and continuous improvement.

Qualifications

• Degree or equivalent qualification, preferably within a life sciences discipline.
• Experience in life sciences, medical devices or similarly regulated industry.
• Knowledge of ISO 13485, 21 CFR, MDSAP, EU IVDD/IVDR and ISO 14971.
• Experience with Electronic Document Management Systems (EDMS).
• Proficiency in Microsoft Word, Excel and PowerPoint.

Responsibilities

• Manage regulatory activities and ensure ongoing compliance.
• Oversee vigilance, regulatory intelligence, change assessments and submissions.
• Act as a liaison with regulatory authorities including MHRA and Swissmedic.
• Coordinate product registrations for UK and Swiss markets.
• Assess regulatory changes and their impact on QMS.
• Support implementation of regulatory and quality requirements across the organisation.
• Maintain and manage technical documentation.
• Advise stakeholders with regulatory guidance at executive level.
• Support development and maintenance of quality and compliance systems.
• Identify opportunities to improve regulatory processes and productivity.

Skills

Attention to detail

Organisational skills

Communication skills

Executive stakeholder communication

Regulatory knowledge

EDMS experience

Microsoft Office

Education

Degree in life sciences

Tools

EDMS

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Peopleforce Recruitment Ltd is recruiting a Regulatory Affairs Specialist for Dundee, office-based, to reinforce the Compliance Team. The role focuses on ensuring that products, processes and quality systems meet UK, EU, Swiss and international regulatory requirements.

You will work with internal stakeholders and regulators to provide regulatory expertise across registrations, vigilance, regulatory intelligence, and technical documentation, supporting quality systems and continuous improvement.