Regulatory Manager

Aurora Lifesciences; United Kingdom; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Aurora Lifesciences is seeking a Regulatory Manager to guide regulatory submissions and approvals for class IIa devices across EU, UK, US and other markets. You will lead regulatory strategy, manage Technical Files, and ensure compliance across product development and post-market activities.

The role requires 5+ years in medical device regulatory affairs, strong documentation skills, and experience with EU MDR transitions, US FDA guidance, and cross-functional teams.

Qualifications

• 5+ years’ experience in regulatory affairs, quality, or compliance within the medical device industry.
• Experience preparing and submitting Technical Files and EU MDR transitions for Class IIa devices.
• Knowledge of EU MDD and MDR requirements, including legacy device considerations.
• Understanding of US medical device regulations and FDA guidance.
• Familiarity with electromechanical medical devices and software components.
• Awareness of non-medical device regulations, e.g., low voltage, EMC, or equivalent international standards.
• Strong documentation, written, and verbal communication skills.
• Proficient in MS Office and Adobe Acrobat.

Responsibilities

• Manage regulatory clearance activities for new and existing devices across global markets.
• Plan and execute medical device submissions, registrations, and renewals.
• Interact with regulatory authorities and auditors to support Technical File reviews, license applications, and compliance audits.
• Compile, review, and maintain regulatory documentation; support development teams to ensure evidence meets regulatory standards.
• Contribute to post-market surveillance, including reporting and data analysis.
• Collaborate with distributors and local representatives to ensure compliance obligations are met.
• Provide strategic guidance on future regulatory pathways in coordination with Product and Sales teams.

Skills

Regulatory submissions

Regulatory affairs

Quality/compliance

Documentation

Cross-functional collaboration

Communication

Tools

MS Office

Adobe Acrobat

Job description

About the Role

Our client, a global leader in high-performance hardware and software solutions used across life sciences and engineering is seeking a Regulatory Manager to join their RA/QA Compliance team.

This role provides the opportunity to work with innovative electromechanical devices, including systems that incorporate software, and support their regulatory strategy across international markets.

Role Overview

You will oversee regulatory submissions and approvals across multiple regions, including the EU, UK, US, and other global markets via distribution networks. You will act as a regulatory ambassador, ensuring all devices meet local and international compliance requirements.

Key Responsibilities

• Manage regulatory clearance activities for both new and existing devices across global markets.
• Plan and execute medical device submissions, registrations, and renewals.
• Interact with regulatory authorities and auditors to support Technical File reviews, license applications, and compliance audits.
• Compile, review, and maintain regulatory documentation; support development teams to ensure evidence meets regulatory standards.
• Contribute to post-market surveillance, including reporting and data analysis.
• Collaborate with distributors and local representatives to ensure compliance obligations are met.
• Provide strategic guidance on future regulatory pathways in coordination with Product and Sales teams.

Working Environment

• Hybrid working with a mix of home-based and office-based activity.
• Based in a city with strong academic and research credentials.
• Standard office hours; no expectation of being on-call outside core hours.

Required Skills and Experience

• 5+ years’ experience in regulatory affairs, quality, or compliance within the medical device industry.
• Experience preparing and submitting Technical Files and supporting EU MDR transitions for Class IIa devices.
• Knowledge of EU MDD and MDR requirements, including legacy device considerations.
• Understanding of US medical device regulations and FDA guidance.
• Familiarity with electromechanical medical devices, including software components.
• Awareness of non-medical device regulations, e.g., low voltage, EMC, or equivalent international standards.
• Strong documentation, written, and verbal communication skills.
• Proficient in MS Office and Adobe Acrobat.

Desirable Skills

• Experience with MDSAP and medical device regulations in participating countries.
• Exposure to cross-functional collaboration on regulatory strategy and product development