Regulatory Affairs Specialist
Salehiya Trading company
مجموع سنوات الخبرة :7 years, 1 أشهر
• Prepares, reviews, and manages submissions for affiliate
regulatory approvals
• Oversee and manage Regulatory Affairs operations and set goals,
ensure that they are met, and be responsible for continuous
process improvement of the assigned Affiliate staff (co-review,
advice).
• Work with the Affiliate Head to identify and recommend
appropriate Regulatory Affairs resources and budget.
• Participate in industry associations on regulatory policy and
regulations; taking regulatory convergence into consideration.
• Participating in preparing SOP, and analyzing risk.
• Perform and control the full ISO 13485 audit cycle including
risk management and control management over operations’
effectiveness, and compliance with all applicable directives and
regulations.
• Consulting with the legal department and advising leadership and
management on compliance matters.
• Developing and providing compliance policies, practices, and
reporting systems, to Identify investigate, and report compliance
issues, irregularities, and violations.
• Tracking and responding to complaints and maintaining records
of compliance activities.
• Preparing and filing compliance reports.
Technical repair and testing of Electronics at Damacles POD project
