Regulatory Specialist II

Description:

Job Purpose
Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process.

Key Responsibilities
• Under minimal supervision, acts 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 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.

Quality Systems Requirements
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.

For those individuals that supervise others, the following statements are applicable:
• 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.

Required Experience
* BS degree and 2-4 years of related experience, or MS degree and 0-2 years of related experience
* Demonstrated background in regulatory affairs (required)
* Proficiency in Microsoft Office suite
* Experience working with regulatory management systems used for archiving and managing submissions; this will be a primary focus area of the role
* Strong written and verbal communication skills, with the ability to collaborate across multiple departments
* Ability to work independently in a minimally supervised environment; must be proactive in seeking guidance when needed
* Team-oriented mindset with a collaborative approach
* Must have a dedicated, professional home office environment with reliable internet connectivity to support remote work responsibilities
*** Candidates with medical writing backgrounds will not be considered for this position.

Preferred Qualifications
* Master's degree in Regulatory Affairs with 0-2 years of related experience
* Experience using Windchill