Regulatory Affairs Lead - Health Data & Research (Remote)

Our Future Health; Greater London; On-site; GBP 70,000 - 80,000; Full time

Job summary

A leading health research charity in Greater London seeks a Regulatory Affairs Lead. This role is essential for developing regulatory pathways for participant feedback. Responsibilities include maintaining regulatory policies and engaging with various authorities to ensure compliance. Candidates should possess proven success in regulatory approvals, experience in quality systems, and strong interpersonal skills. Competitive salary, generous benefits, and an inclusive work culture are offered.

Benefits

Basic salary from £70,000 per annum

Generous Pension Scheme

30 Days Holiday

Enhanced Parental Leave

Cycle to Work Scheme

Home & Tech Savings

£1,000 Employee Referral Bonus

Wellbeing Support

Flexible working arrangements

Qualifications

• Experience within the charitable health or research sectors.
• Proven success in regulatory approvals.
• Strong background in ISO quality systems.

Responsibilities

• Develop regulatory pathways for health information feedback.
• Lead development of regulatory policies and briefings.
• Monitor regulatory trends and translate changes into policy.

Skills

Regulatory approvals in the UK / EU

Regulatory policy development in genetic testing

Working with quality systems (ISO 13485, ISO 15189)

Engaging with regulatory agencies (MHRA, CQC)

Strategic thinking

Cross-functional project leadership

Excellent communication skills

Interpersonal skills

Sound judgement

Experience with complex IVD Workflows

UK DPA 2018 GDPR familiarity

Job description

A leading health research charity in Greater London seeks a Regulatory Affairs Lead. This role is essential for developing regulatory pathways for participant feedback. Responsibilities include maintaining regulatory policies and engaging with various authorities to ensure compliance. Candidates should possess proven success in regulatory approvals, experience in quality systems, and strong interpersonal skills. Competitive salary, generous benefits, and an inclusive work culture are offered.