Regulatory Affairs Specialist
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Experience and Knowledge:
- 2 to 5 years experience in regulatory affairs and/or reimbursement with demonstrated experience in the full range of submissions and in dealing with local regulatory agencies
- Work experience in a MNC in a similar industry is preferred.
- Experience writing technical reports
- Demonstrated experience with the Medical Device Regulations and Common Submission Dossiers Template (CSDT).
- Knowledge of country regulations, local regulatory agencies and ASEAN harmonization roadmap is an advantage.
- Computer literacy including sound knowledge of the MS Office suite of software
- Proven evidence of Medtronic Traits:
- Mission Values: Consciously works to bring the Mission alive
- External Focus: Customer responsive, competitive and market driven, leads and supports Change
- Clear Thinking: Translates complexity into simplicity, articulates crisply and clearly
- Driven to Win: Passionate and driven, makes tough decisions in difficult situations
- Inspires Others: Authentic and sets a vision to inspire performance and engage others
- Executes: Takes accountability for and consistently delivers consistent decisions, actions and results
- Boundaryless: Breaks down silos, collaborates across organizational boundaries
- Global: Culturally agile, strives to understand diverse market needs and responds with creative and effective solutions
- Integrity and Compliance: Practice the highest ethical standards and integrity in every aspect of my job.
Qualifications:
- Bachelor’s degree in Pharmacy or any Science course or Biomedical Engineering.
- RAPS certification or any equivalent RA certification or accreditation is an advantage.
