Regulatory Affairs Specialist Ii

hace 2 semanas

Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

**Work mode**:Hybrid

**Onsite Location(s)**:Buenos Aires, C, AR

**Additional Locations**: N/A

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing - whatever your ambitions.

**About the role**
- Develop local strategies for regulatory approval in collaboration with Marketing, Planning and International Division teams.
- Coordinate, compile and submit regulatory submissions for new products, revalidations and modifications to ANMAT.
- Consolidate documentary packages to send to Bolivia, Paraguay and Uruguay.
- Review product changes and assess their regulatory impact.
- Review promotional materials.
- Represent Regulatory Affairs in cross-functional projects, providing regulatory feedback and guidance, including participation in process changes, continuous improvement efforts and acceleration towards digital transformation.

**What we are Looking for in you**

**Required Qualifications**
- Level of education required: University degree or advanced student in Pharmacy, Biochemistry, Health Technology, Biomedical Engineering or related fields
- Languages and level achieved: Advanced English
- Experience in Medical Device Regulatory Affairs. 3 - 4 years

**Preferred Qualifications**
- Organized, able to follow established processes.
- Ability to manage databases in software and systems.
- Effective communication of complex ideas, both verbally and in writing, good writing skills.
- Team player with excellent interpersonal skills and strong problem-solving skills

**Requisition ID**:598225

**Job Segment**:Regulatory Affairs, Compliance, Biomedical Engineering, Law, Medical Device, Legal, Engineering, Healthcare

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