Senior Regulatory Affairs Lead – Global Compliance & Strategy

AliveDx Suisse SA; Penicuik; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A leading diagnostic insights company based near Penicuik, Edinburgh, is looking for a Senior Regulatory Affairs Officer. This full-time role involves leading regulatory strategy for products internationally, ensuring compliance with various regulations, and mentoring junior staff. You will liaise with regulatory authorities, manage license registrations, and contribute to continuous improvement of regulatory processes. The position offers a dynamic environment with flexible benefits including medical cover and additional annual leave.

Benefits

Private medical cover

Life assurance

Flexible working environment

Access to marketplace discounts

Qualifications

• Experience with regulatory strategy execution across multiple geographies.
• Ability to identify and apply regulatory requirements.
• Strong communication skills with internal and external stakeholders.

Responsibilities

• Lead regulatory strategy for product approvals worldwide.
• Maintain regulatory documentation compliant with cGMP and ISO standards.
• Supervise junior regulatory staff and contribute to their development.
• Liaise with regulatory agencies for compliance and guidance.

Skills

IVDR implementation experience

Regulatory application preparation

Excellent knowledge of regulatory requirements

Ability to provide regulatory guidance

Job description

A leading diagnostic insights company based near Penicuik, Edinburgh, is looking for a Senior Regulatory Affairs Officer. This full-time role involves leading regulatory strategy for products internationally, ensuring compliance with various regulations, and mentoring junior staff. You will liaise with regulatory authorities, manage license registrations, and contribute to continuous improvement of regulatory processes. The position offers a dynamic environment with flexible benefits including medical cover and additional annual leave.