Regulatory Affairs Specialist

Sientra is currently searching for a Regulatory Affairs Specialist to join our growing Regulatory team. The Regulatory Affairs Specialist is responsible for the indexing and maintenance of all regulatory documents, for assisting in the preparation of regulatory submissions and for coordinating all activities related to assembling regulatory submissions. The Regulatory Affairs Specialist is also responsible for performing requested searches of regulatory and medical device databases in support of Regulatory Affairs Department activities and for monitoring current and proposed regulatory requirements. Other duties may be assigned.

Additional Duties and Responsibilities

* Initiates and coordinates information to prepare regulatory documentation packages for review and submission to regulatory agencies.

* Writes and reviews documentation associated with regulatory submissions, and prepares clear and concise summaries of technical and other information as needed for submissions.

* Completes quality control of regulatory documentation prior to submission

* Plans, prepares and manages timelines for assigned regulatory submissions

* Initiates and compiles materials for license renewals, updates and registrations.

* Reviews labeling for regulatory compliance and proposes updates as necessary.

* Maintains current expertise and communicates changes and meaningful trends in the regulatory environment in the U.S. and pertinent international jurisdictions.

* Supports and participates in the development of Regulatory Department systems and processes

* Other duties may be assigned.

Education and Experience

* Bachelor's degree, in engineering, science, or a health-related field

* Minimum 2-4 years of regulatory submission preparation or equivalent experience

* Detail oriented with excellent documentation skills, including record maintenance and traceability

* Strong verbal communication and written correspondence skills

* General knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirements

* Ability to work as part of a project team, as well as independently

* Excellent prioritization and organizational skills with ability to work on multiple tasks/projects in a fast-paced environment

If you would like to apply for this position, please email your resume to careers@sientra.com.