Regulatory Consultant

We are looking for an experienced and detail-oriented Regulatory Affairs Consultant to join our team on-site in Denmark. This role is ideal for someone with a strong background in medical device regulations who thrives in a collaborative, fast-paced environment. You will play a key role in ensuring compliance with EU MDR and other global regulatory requirements.

Key Responsibilities

• Develop and execute regulatory strategies for medical device submissions in the EU and other international markets.
• Prepare and maintain technical documentation in compliance with EU MDR (2017/745), ISO 13485, and other applicable standards.
• Serve as the primary contact for Notified Bodies and regulatory authorities.
• Monitor regulatory changes and assess their impact on product compliance.
• Support product development teams with regulatory guidance throughout the product lifecycle.
• Manage post-market surveillance activities and ensure timely reporting of adverse events.
• Participate in internal and external audits and inspections.
• Provide training and mentorship on regulatory topics to internal stakeholders.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
• 3-5+ years of regulatory affairs experience in the medical device sector.
• Strong knowledge of EU MDR, ISO 13485, and CE marking processes.
• Experience with international regulatory submissions (e.g., FDA, Health Canada, TGA) is a plus.
• Excellent communication and documentation skills.
• Fluent in English; proficiency in Danish is advantageous.
• Must be eligible to work in Denmark and available for on-site work.