Regulatory Affairs – United Kingdom

Resourcing Life Science; United Kingdom; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading life sciences company in the UK is seeking a Regulatory Affairs Specialist. The role involves managing regulatory submission timelines, ensuring compliance with international regulations, and collaborating with cross-functional teams. Candidates should have a minimum of 5 years of experience and be fluent in English. This position is crucial for maintaining product compliance and facilitating market access.

Qualifications

• Minimum 5 years of experience in regulatory affairs.
• Fluency in English is required.

Responsibilities

• Establish and manage regulatory submission timelines.
• Prepare and file global medical device applications.
• Engage with regulatory authorities for product registrations.
• Author and maintain EU MDR-compliant technical documentation.
• Conduct global regulatory impact assessments.
• Act as the regulatory representative on cross-functional teams.
• Interpret and apply international regulations.
• Review and approve product labeling.
• Support and participate in inspections and audits.

Skills

Regulatory submission management

Regulatory compliance

Cross-functional collaboration

Technical documentation

Fluent English

Job description

What to Expect

• Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
• Prepare and file global medical device applications and amendments, ensuring timely market access.
• Engage with regulatory authorities and distribution partnersto support product registrations
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
• Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
• Review and approve product labelingto ensure compliance with global regulatory requirements.
• Support and participate in inspections and auditsconducted by global regulatory authorities.

Requirements

• Minimum 5 years of Experience
• Fluent English

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]

Tagged as: Regulatory Affair