Expanding our team of experts, we are seeking a Regulatory Compliance Specialist to join us in Castiglione Olona.
About the Role
We're looking for a highly skilled individual to ensure our medical device products meet regulatory requirements in line with MDR (EU) 2017/745, Italian regulations, and relevant quality standards.
Key Responsibilities
- Prepare, manage, and maintain regulatory documentation to support product registration and approval.
- Monitor and interpret evolving regulatory requirements and advise internal stakeholders accordingly.
- Collaborate cross-functionally with Product Management, Supply Chain, Legal, and Global RA teams to ensure regulatory compliance throughout the product lifecycle.
- Participate in internal training sessions and help create presentations and documentation for regulatory updates.
- Actively contribute to the launch of new products from a regulatory standpoint.
Requirements
- 1–2 years of experience in Regulatory Affairs within the medical device sector.
- Fluency in Italian and English is essential.
- Experience with Root Cause Analysis and CAPA methodologies.
- A desire to grow your regulatory career in a structured yet flexible role with long-term potential.
Benefits
This role offers a dynamic working environment with opportunities for growth and development. You will work closely with a diverse and collaborative team in a growing regulatory function. With around 420 employees, we operate exclusively in Italy and pride ourselves on a close-knit, innovative, and collaborative culture.
What We Offer
We value diversity and inclusion, and we welcome applications regardless of gender, nationality, ethnic and social origin, religion, ideology, disability, age, or sexual orientation and identity.