Regulatory Affairs – United Kingdom

Resourcing Life Science; United Kingdom; On-site; GBP 40,000 - 70,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Regulatory Affairs specialist to manage submissions and ensure compliance across global markets. Responsibilities include regulatory documentation, collaboration with cross-functional teams, and interaction with regulatory authorities. The ideal candidate will have at least 5 years of experience and be fluent in English, showcasing proven expertise in navigating international regulations.

Qualifications

• Minimum 5 years of experience in Regulatory Affairs.

Responsibilities

• Establish and manage regulatory submission timelines for global markets.
• Prepare and file global medical device applications and ensure timely market access.
• Engage with regulatory authorities and maintain EU MDR-compliant documentation.

Skills

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 [e-mail]

Tagged as: Regulatory Affair