EMEA Regulatory Affairs Leader — Medical Devices

CooperVision; Gorinchem; Hybrid; EUR 120,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation

Career development

Job summary

CooperVision is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy across UK/I&I, BeNeLux and Nordic regions. You will guide submissions from concept to post market and drive regional RA processes while collaborating with global teams.

You will oversee regulatory activity, maintain documents, and mentor colleagues to ensure compliance with ISO 13485, EU MDR and related requirements across multiple sites, including UK, NL, and Sweden.

Qualifications

• 6-8 years of medical device regulatory experience.
• Technical writing experience. Evaluating manufacturing changes for impact on regulatory submissions.
• Experience with MDD and MDR in medical devices.
• Ability to provide quick, salient analyses and actionable plans for business needs.
• Capacity to build relationships and influence decision makers.

Responsibilities

• Review and approve regulatory documents for current and new products in assigned markets.
• Maintain submission documents and databases for timely regulatory information access.
• Update and remediate regulatory files; communicate status across regions and departments.
• Mentor junior team members on submissions.
• Ensure regional regulatory requirements are monitored and communicated to stakeholders.
• Support Notified Bodies and coordinate CE marking activities.

Skills

Regulatory expertise

Medical devices

Technical writing

MDD/MDR

ISO 13485

Stakeholder management

Agile PM

Tools

Electronic document management systems

Agile Project Management system

Job description

CooperVision is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy across UK/I&I, BeNeLux and Nordic regions. You will guide submissions from concept to post market and drive regional RA processes while collaborating with global teams.

You will oversee regulatory activity, maintain documents, and mentor colleagues to ensure compliance with ISO 13485, EU MDR and related requirements across multiple sites, including UK, NL, and Sweden.