Regulatory Affairs Officer

Job Description

We are looking for a knowledgeable Regulatory Affairs Officer to join our dynamic regulatory team in Worcester. The ideal candidate will have a strong background in compliance management and a deep understanding of the regulations governing the healthcare industry.

Responsibilities

• Develop and implement regulatory strategies for new products.
• Monitor ongoing compliance with existing products.
• Coordinate with marketing and R&D to ensure compliance in promotional activities.
• Analyse regulatory changes and their implications for the business.
• Provide input on risk management strategies.
• Prepare and present regulatory updates to senior management.
• Facilitate cross-departmental communication regarding compliance issues.
• Document policies and procedures for regulatory affairs.

Requirements

Education

• Bachelor's degree in Regulatory Affairs or related field
• Postgraduate qualification is advantageous

Experience

• 5+ years of experience in regulatory affairs in pharmaceuticals or medical devices.

Technical Skills

• Knowledge of NHS and EU regulations
• Project Management

Soft Skills

• Interpersonal Skills
• Attention to Detail

Certifications

• ISO 9001 Lead Auditor

Languages

• English: Fluent

Advantageous

• Proficiency in regulatory software tools: Experience using software for regulatory compliance and submissions.
• Knowledge of international regulatory requirements: Understanding regulations in multiple jurisdictions is a plus.

Benefits

• Generous leave entitlements
• Employee assistance program
• Ongoing professional development opportunities
• Social events and team-building activities

Company Culture

• Inclusivity: Our company values diversity and promotes an inclusive culture where all voices are welcomed.
• Work-Life Balance: We encourage a healthy work-life balance, offering flexible working conditions.