Senior Regulatory Affairs Specialist - Hybrid, Equity & Growth

The Opportunity Hub UK Ltd

Reading

Ibrido

GBP 50.000 - 75.000

Tempo pieno

2 giorni fa

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Vantaggi offerti da questo lavoro

Equity in the business

Learning and development budget

Hybrid working from Reading

Descrizione del lavoro

The Opportunity Hub UK Ltd in Reading is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions, liaise with UK and EU authorities, and shape the regulatory strategy for new healthcare products. You will review documentation, ensure compliant labelling, and work with quality, clinical, and commercial teams to keep launches on track.

You will navigate UK MHRA and EU MDR/IVDR frameworks with precision, communicate changes clearly, and drive post-market surveillance to

Competenze

Experience in regulatory affairs within healthcare, medtech or pharmaceuticals.
Working knowledge of UK MHRA and EU MDR/IVDR frameworks.
Sharp attention to detail with minimal room for guesswork.
Comfort communicating with regulators, auditors and internal stakeholders.
Able to thrive in a startup where priorities shift and you wear multiple hats.

Mansioni

Lead regulatory submissions and liaise directly with UK and EU regulatory bodies on product approvals.
Review technical documentation, labelling and clinical evidence for compliance before release.
Build and maintain regulatory strategy for new product launches from development to market.
Track regulatory changes and translate them into practical actions for the team.
Collaborate with quality, clinical and commercial functions to avoid delays at the regulatory stage.
Own post-market surveillance reporting and flag risks early.