Regulatory Compliance Specialist

ZipRecruiter; England; On-site; GBP 30,000 - 60,000; Part time

Job summary

An innovative firm is seeking a Regulatory Compliance Specialist with expertise in MHRA-registered medical devices, especially Software as a Medical Device (SaMD). This role involves leading regulatory approval processes, ensuring compliance with UK regulations, and supporting clinical validation and pilot trials. The ideal candidate will have direct experience with MHRA submissions and a solid understanding of medical device integration in healthcare settings. Join a dynamic team and contribute to shaping regulatory strategies in a startup environment that values your insights and expertise.

Qualifications

• Experience with MHRA-registered medical devices, particularly Software as a Medical Device.
• Hands-on experience in regulatory approvals and compliance.

Responsibilities

• Lead MHRA approval processes for medical devices and SaMD.
• Ensure compliance with UKCA marking, CE marking, and MDR requirements.

Skills

Regulatory Compliance

MHRA Submissions

Clinical Validation

Risk Management

Medical Device Integration

Job description

Job Description

We are looking for a Regulatory Compliance Specialist with experience in MHRA-registered medical devices, particularly Software as a Medical Device (SaMD). The candidate must have hands-on experience in regulatory approvals and compliance, with a good understanding of medical device integration processes in healthcare settings.

Key Responsibilities:

1. Lead MHRA approval processes for medical devices/SaMD.
2. Ensure UK regulatory compliance (UKCA marking, CE marking, MDR requirements).
3. Support clinical validation, simulation studies, and pilot trials for regulatory approval.
4. Oversee risk management, post-market surveillance, and documentation.
5. Work alongside the technical team to ensure regulatory requirements align with SaMD integration into healthcare systems.

What We’re Looking For:

1. Direct experience in MHRA submissions and regulatory approval.
2. Knowledge of UK medical device compliance and certification requirements.
3. Experience in clinical validation, simulation studies, or pilot testing.
4. Familiarity with SaMD integration in healthcare workflows (not hands-on technical development, but an understanding of regulatory implications).
5. Ability to work in a startup environment and contribute to regulatory strategy.
6. Open to part-time employment.

Apply now by emailing your CV to [e-mail] or share with someone who might be a good fit.