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.
FAQs
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