Regulatory Affairs Consultant
At Zi-Medical, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
Job Purpose: Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process and sustaining engineering projects.
- Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
- Assists with developing and implementing regulatory strategies for new and modified medical devices
- Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product and manufacturing process development cycle.
- Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
- Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
- Support and maintain Quality initiatives in accordance with BSC Quality Policy.
- Continuously assess ways to improve Quality.
- Supports efforts to improve collaboration, experience sharing and best practices within the department and division.
- Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
- 2 + years Regulatory Affairs or related experience, medical industry experience preferred.
- Working knowledge of FDA, EU and international regulations for medical devices.
- General understanding of product development process and design control.
- General understanding of regulations applicable to the conduct of clinical trials.
- Ability to manage several projects.
- Proficiency with Microsoft Office.
- Effective research and analytical skills.
- Effective written and oral communication, technical writing and editing skills.
- Ability to work independently with minimal supervision. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Our mission at is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Seniority Level: Entry level
Industry: Medical Device
Employment Type: Contract
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