Must be xpert in Both Manual and Automation testing As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. CORE JOB RESPONSIBILITIES: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core job responsibilities for this function may include: Strategic Planning: · Assist in SOP development and review. · Provide regulatory input to product lifecycle planning. · Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. · Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. · Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. · Determine trade issues to anticipate regulatory obstacles. · Determine and communicate submission and approval requirements. · Participate in risk-benefit analysis for regulatory compliance. Premarket: · Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Desired Skills: Computer Engineer Keywords: Other - Engineering & Manufacturing, Engineer, Computer