Regulatory Affairs Specialist
📋 Role Overview & Responsibilities
Company DescriptionVitaTek is a leading medical device manufacturer based in Woodbury, MN. As the largest private medical device manufacturer in the state of Minnesota, we offer a comprehensive range of in-house medical device development services, including research, design, development, FDA regulatory, user testing, manufacturing, sterilization, packaging, warehousing, and sales and marketing. Our commitment to innovation and quality has made us a trusted partner in the healthcare industry.
Role DescriptionThis is a full-time on-site role for a Senior Regulatory Affairs Specialist at VitaTek. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and managing regulatory documentation for our medical devices. This includes preparing and submitting regulatory submissions, monitoring changes in regulations, and advising cross-functional teams on regulatory compliance matters. You will collaborate closely with internal and external stakeholders to ensure regulatory compliance throughout the product lifecycle.
QualificationsRegulatory Affairs, Regulatory Compliance, and Regulatory Requirements various geographiesExperience in preparing and submitting regulatory submissionsStrong knowledge of medical device regulations and standardsExcellent verbal and written communication skillsAttention to detail and ability to analyze complex informationAbility to work independently and collaboratively in a cross-functional team environmentBachelor's degree in a science or engineering discipline, or related fieldExperience in FDA or other regulatory agency inspections is a plus
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This position is located in Woodbury, MN with potential relocation and sponsorship assistance depending on candidate qualifications.
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