Кариера во Рош Македонија
Aктивни огласи за вработување во Рош Македонија
20. октомври 2021 г.
Medical Device Regulatory Specialist (maternity leave)
Regulatory Affairs Specialist I
Accountable for local regulatory activities for medical devices within Roche Macedonia
- Responsible for obtaining and maintaining medical device licenses during product life cycle.
- Develop and maintain working relationship with national regulatory authorities and colleagues within relevant Roche divisions/departments.
- Ensure regulatory compliance for medical devices released to market according to marketing authorizations
- Complies with all relevant local, quality and Global Regulatory requirements and standards
Core Competencies, Skills
- Time Management: exercising conscious control over the amount of time spent on specific activities, especially to increase efficiency or productivity
- Teamwork and collaboration: develops and maintains effective relationships at all levels, internally and externally. Is trustworthy and reliable, follows through commitments.
- Communication: communicates in a highly genuine, authentic manner, models and encourages clear, open two-way communication, listens actively.
- Focus: demonstrates deep and broad knowledge and expertise within own professional field. Oscillates between big picture and detail as needed. Displays commitment to delivering high quality outputs.
- Strategic agility: links his/her responsibilities with the mission of the whole organization. Regularly updates plans to reflect changing circumstances. Focuses on activities that provide the most value.
- Regulatory knowledge: basic understanding of IVD & MD, drug development and ICH regulatory guidelines.
Minimum Qualifications and Experience
- University Degree preferably in life science discipline (MD or pharmacy)
- 1-2 years’ experience in regulatory affairs, preferably in regulatory submissions or labelling
- Language skills: fluency in written and spoken English
The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
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