International Regulatory Affairs Manager

hace 1 semana

Madrid, España Straumann Group A tiempo completo

**International Regulatory Affairs Manager**

Straumann Group is synonymous with premium quality, precision and innovation that deliver confidence in dentistry, backed by the world's largest scientific network. As a global leader in implant dentistry, we offer cutting-edge innovations that are considered industry benchmarks and disruptive technological breakthroughs, backed by long-term scientific evidence.

**On this role, your primary responsibilities include**:
**1) Product registration in assigned countries**
- Collaborate with the Regulatory Affairs staff of subsidiaries and distributors in assigned countries
- Provide registration strategy in the assigned countries
- Ensure timely submissions, approvals of new products and product license Life Cycle Management
- Plan and track registration plan and status using the various Orbit Launch Management System and the MSP.
- Keep the company updated of the regulations in the countries

**2) Be the point of contact for Regulatory Affairs related matters to the assigned countries**

**3) Support International Regulatory Affairs improvement processes**

**Requirements**:

- Have a minimum 3 years of professional experience in regulatory affairs, preferably in medical device industry
- University Degree
- Knowledge of ISO13485, MDD 93/42 EEC, EU MDR
- Knowledge and experience in MD regulations in countries, ideally also in Latam countries.
- Problem solving skills
- Distinct communicative, professional, independent and team oriented behavior
- Ability to work in cross-functional, cross-culture teams
- Have very strong communication skills of written and spoken English, ideally also in Spanish.

**What we offer you**:

- A unique opportunity to grow your career in a world market leader in dental technology.
- A collaborative and supportive work environment where innovation and creativity are encouraged.
- Access to cutting-edge technologies and methodologies
- Competitive compensation and benefits package.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

**Employment Type**:Full Time

**Alternative Locations**:Spain : Madrid

**Travel Percentage**:0 - 10%

**Requisition ID**:18716

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