Senior Regulatory Affairs Specialist

The Opportunity Hub UK Ltd; Aberdeen City; Hybrid; GBP 47,000 - 68,000; Full time

Benefits offered by this job

Hybrid working

Private medical insurance

Pension

Generous annual leave

Bonus scheme

Professional development

Job summary

The Opportunity Hub UK Ltd is seeking a Senior Regulatory Affairs Specialist in Aberdeen. You will own regulatory submissions for healthcare products across UK and international markets, ensuring compliance with UK MDR, EU MDR and other frameworks.

Join a growing SME and collaborate with quality, R&D and commercial teams. The role offers hybrid working, private medical insurance, pension contributions, generous leave, and a clear path for professional development as the company grows.

Qualifications

• Experience in regulatory roles within healthcare, medical devices, or pharmaceuticals.
• Knowledge of UK MDR and EU MDR regulatory requirements.
• Excellent written communication for precise regulatory submissions.
• Ability to manage multiple submissions and deadlines.
• Methodical approach with ability to push back when needed.
• Experience working with technical and non-technical teams.

Responsibilities

• Preparing and submitting regulatory documentation for healthcare products across UK and international markets.
• Reviewing product labelling, technical files, and clinical documentation for compliance before submission.
• Liaising directly with regulatory bodies including the MHRA to manage approvals and respond to queries.
• Monitoring changes in healthcare regulation and translating them into practical guidance for internal teams.
• Supporting post-market surveillance activities and managing any related reporting obligations.
• Working alongside quality, R&D, and commercial teams to keep product development aligned with regulatory requirements.

Skills

Regulatory affairs

UK MDR

EU MDR

Regulatory writing

Submission management

Cross-functional collaboration

Job description

Make your mark as a Senior Regulatory Affairs Specialist in the Healthcare sector, based in Aberdeen.

Healthcare regulation doesn't stand still. New device requirements, shifting MHRA guidance, and post-market surveillance obligations mean a growing SME healthcare business needs someone who can keep pace without losing momentum. This established and expanding company, based in Aberdeen, is looking for a Senior Regulatory Affairs Specialist to take ownership of that work. It's a role with real weight behind it.

Here’s what you'll be doing:

Preparing and submitting regulatory documentation for healthcare products across UK and international markets

Reviewing product labelling, technical files, and clinical documentation for compliance before submission

Liaising directly with regulatory bodies including the MHRA to manage approvals and respond to queries

Monitoring changes in healthcare regulation and translating them into practical guidance for internal teams

Supporting post-market surveillance activities and managing any related reporting obligations

Working alongside quality, R&D, and commercial teams to keep product development aligned with regulatory requirements

Here are the skills you'll need:

Solid experience in a regulatory affairs role within healthcare, medical devices, or pharmaceuticals

Working knowledge of UK MDR, EU MDR, and relevant international regulatory frameworks

Strong written communication. Regulatory submissions leave no room for ambiguity

Confidence managing multiple submissions and deadlines without things slipping

A methodical approach paired with the judgement to know when to push back on a process

Comfortable working cross-functionally, including with technical and non-technical colleagues

Key perks and benefits:

Salary of £47,000 to £68,000, depending on experience

Hybrid working, with time split between home and the Aberdeen office

Private medical insurance and pension contribution

Generous annual leave with flexible working arrangements

Bonus scheme and genuine scope for professional development as the company grows

Why pursue a career in Healthcare?

Healthcare regulation is one of those fields that rewards precision and gets more important every year, not less. Aberdeen has a growing cluster of healthcare and life sciences employers, which makes it a sound base for anyone building a long-term career in this space. Get good at this work and doors open. Fast.