Sr. Regulatory Affairs Specialist

Job description

Job Description: The Sr. Regulatory Affairs Specialist will be primarily responsible for supporting the development of RA strategies for new product development for a range of dental restorative, endodontic, and rotary products. Responsibilities include preparing/submitting regulatory filings for US 510(k)s, Canada, and EU MDR. Medical devices Essential Duties and Responsibilities: Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. - Working primarily independently, applies forward thinking when drafting and proposing regulatory strategies for sustaining and new products including but not limited to creating action plans and supporting the completion of milestones. - Reviews and interprets applicable standards, regulations, and directives for dental devices to ensure compliance with applicable regulations. - Represents the RA function on core teams w...