EMEA Regulatory Affairs Lead – Medical Devices

CooperVision; Southampton; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

LinkedIn Learning

Professional development

Job summary

CooperVision is seeking a Principal Regulatory Affairs Specialist to lead regulatory direction across the UKI, BeNeLux and Nordic clusters, from concept to launch and post market. You will manage submissions, maintain regulatory files, and interact with government bodies to ensure compliance with UK, EU, ACE and MENA requirements.

Strong technical writing and cross‑functional leadership are essential for this role.

Qualifications

• 6-8 years of regulatory experience in medical devices.
• Technical writing experience with evaluating changes for regulatory submissions.
• Experience with MDD and MDR in medical devices.
• Understanding of ISO 13485 requirements and EU medical device regulations.
• Ability to influence decision-makers and build relationships.

Responsibilities

• Register and maintain regulatory submissions for UKI, BeNeLux and Nordic markets.
• Monitor regional regulatory requirements and communicate changes to management and partners.
• Prepare and support Notified Body interactions and technical documentation.
• Represent regulatory affairs in cross-functional projects and ensure compliance across regions.

Skills

Regulatory strategy

Cross-functional leadership

Technical writing

MDD/MDR knowledge

ISO 13485 knowledge

Regulatory submissions

Tools

Agile Project Management system

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

CooperVision is seeking a Principal Regulatory Affairs Specialist to lead regulatory direction across the UKI, BeNeLux and Nordic clusters, from concept to launch and post market. You will manage submissions, maintain regulatory files, and interact with government bodies to ensure compliance with UK, EU, ACE and MENA requirements.

Strong technical writing and cross‑functional leadership are essential for this role.