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Regulatory Affairs Specialist
1 week ago
This role is designed to support the regulatory department in ensuring efficient and compliant business processes and environment. As a Regulatory Affairs Specialist, you will execute tasks to evaluate product and software changes in consideration of regulatory guidance documents and regulations.
Your responsibilities will include providing regulatory input to product lifecycle planning, evaluating proposed software, hardware and manufacturing changes for regulatory filing strategies, assisting in the development of regional regulatory strategy and updating it based on regulatory changes, participating in risk benefit analysis for regulatory compliance, and assisting in the preparation and review of regulatory submissions to authorities.
You will also assist with compliance with product postmarketing approval requirements. A Bachelor's Degree in a science or engineering field is preferred.
This position does not require previous regulatory experience, but you must have 2 years' experience in software verification/validation, software quality assurance or as a Medical Technologist with familiarity of software-driven clinical analyzers. Experience in a related area such as quality assurance, research and development/support, scientific affairs, operations, or regulatory area with software knowledge is also acceptable.
You will be responsible for communicating effectively verbally and in writing, writing and editing technical documents, creating project plans and timelines, and making regulatory submissions for medical devices.