Regulatory Affairs Specialist

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.