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Senior Regulatory Affairs Specialist

Company: Sientra
Location: Santa Barbara
Posted on: December 4, 2019

Job Description:

Sientra is searching for Senior Regulatory Affairs Specialist to join our growing global team!Essential Duties and Responsibilities The Senior Regulatory Affairs Specialist is responsible for implementing regulatory strategies and providing guidance on regulatory issues. The Senior Regulatory Affairs Specialist is also responsible for preparation and submission of documentation for regulatory registration of Sientra products. -The position serves as a role model in the areas of regulatory, leadership, teamwork, customer focus and continuous improvement.Other duties may be assigned.Additional Duties and Responsibilities - - - - - - -Develop and implement Sientra's Regulatory Program to ensure product approval and adoption within the US and international standards. - - - - - - -Perform Regulatory intelligence searches, determine regulatory requirements and develop plans to comply with national laws in the US and throughout the world. - - - - - - -In conjunction with regulatory consultants, plan, prepare, submit, and coordinate new product notifications, Technical Files/Dossiers, and regulatory submissions for various countries. - - - - - - -Generate and coordinate the required reports for regulatory compliance. - - - - - - -Maintain active files for all products registered by the company or the distributor to ensure compliance. - - - - - - -Reviews labeling for regulatory compliance and proposes updates, as necessary. - - - - - - -Maintains regulatory intelligence database - - - - - - -Other duties may be assigned.Requirements (Education, Certificates, Licenses, Registrations, etc.)Master's Degree, preferably in a health-related fieldMinimum 5 years of regulatory submission preparation or equivalent experience3-5 years of experience in International Regulatory submissions preferredDetail oriented with excellent documentation skills, including record maintenance and traceabilityStrong verbal communication and written correspondence skillsEffective research and analytical skillsStrong technical writing and editing skills requiredIn-depth knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirementsAbility to work as part of a project team, as well as independentlyExcellent prioritization and organizational skills with ability to work on multiple tasks/projects in a fast-paced environment

Keywords: Sientra, Santa Barbara , Senior Regulatory Affairs Specialist, Other , Santa Barbara, California

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