International Regulatory Affairs Specialist
2 settimane fa
About the Role
We are seeking a skilled International Regulatory Specialist to join our Regulatory Affairs team in Bussolengo, Italy. As a key member of our team, you will play a critical role in ensuring the timely completion of global product international regulatory submissions, maintaining full compliance with all applicable global regulatory requirements and internal product/project goals.
Key Responsibilities
- Program, prepare and maintain up-to-date International product/facility(ies) submissions including international registrations and/or license applications, according to approved Budget Sales.
- Identify, plan, and collect regulatory submission documents for International markets under minimal supervision, in collaboration with Global Company(ies) departments.
- In collaboration with Global RA – Global Regulatory Intelligence and Regulatory Technical Product members, verify that all domestic and International Regulatory documents are adequately prepared and collected before the international Product(s) ' Application registrations.
- Provide in a timely manner the RA Regulatory Intelligence Specialist (RIS) of any regulatory product registration/submission information status to enable the RIS Specialist to update the RAMS platform on time.
- Contribute to prepare regulatory strategies for new/modified products in the planned markets.
- Provide market regulatory affairs support during external inspections (FDA, NBs, Regulatory Agency, etc.).
- Plan and support the Regulatory Administration specialist for the preparation of Free Sales Certificate and any International documents to be legalized.
- Collaborate during Internal and Third Party Audits for Device Marketing Authorization and Facility Registration process.
- Manage any change(s) by ECO in Oracle system.
Requirements
- Technical degree.
- 3+ years in a similar position, preferably in a Medical Device Company.
- Excellent English written and spoken required.
- Good management skills and relationship skills.
What We Offer
- Full-time job.
- Fixed-term contract of 12 months.
- Salary package range: 35.000/40.000 euro.
Join Our Team
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