Regulatory Affairs Specialist – Device

Novo Nordisk

Regulatory Affairs Specialist overseeing regulatory strategy for drug-device combination products. Collaborating with cross-functional teams to secure global regulatory approvals.

Posted 5/28/2026full-timeSøborg • 🇩🇰 DenmarkSeniorLead💰 DKK 742,600 - DKK 1,091,600 per yearWebsite

About the role

Key responsibilities & impact

Support selected projects and products in the Novo Nordisk portfolio
Provide strategic and scientific input to support development
Secure regulatory approvals, and ensure compliance with evolving global regulations
Lead and drive strategic regulatory device activities for drug-device combination products
Plan, prepare, and lead health authority interactions and meetings
Identify regulatory risks and opportunities, and provide clear recommendations

Requirements

What you’ll need

A Master’s degree and/or PhD in a relevant scientific field
Extensive experience from the pharmaceutical industry and/or a health authority
Minimum 8 years of experience within Regulatory Affairs, with at least 5 years focused on Drug–Device Combination Products
Strong project management skills and the ability to navigate complex stakeholder landscapes
Excellent English communication skills, both written and spoken
Ability to work effectively in multidisciplinary, international teams

Benefits

Comp & perks

Health insurance
401(k) matching
Professional development opportunities
Flexible working hours
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory AffairsDrug-Device Combination ProductsProject ManagementRegulatory ApprovalsComplianceRisk IdentificationStrategic InputHealth Authority InteractionsScientific Input

Soft Skills

CommunicationStakeholder ManagementTeamworkLeadershipStrategic Thinking

Certifications

Master’s DegreePhD