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Regulatory Affairs Specialist, Medical Device

Medtronic
Medtronic (Bangkok, Bangkok City, Thailand)
Bangkok, Thailand 🇹🇭
Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.

About this position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Responsibilities

Responsibilities may include the following and other duties may be assigned.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Requirements

Required Knowledge and Experience:
• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R.• 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.