Regulatory Affairs Specialist | Medical Device

Enovis•Austin, TX

1d•Hybrid

About The Position

The Regulatory Affairs Specialist will work with supervision to bring new and modified medical devices to market and ensure ongoing compliance. The Regulatory Affairs Specialist will be the regulatory representative on product development teams and will be responsible for developing regulatory strategies, authoring submissions, and assessing design and manufacturing changes for wide range implantable products.

Requirements

Bachelor’s degree with a minimum of 2 years of medical device industry experience
Prior experience with regulatory submissions, such as PMA or 510(k)
Working knowledge of FDA and international regulations for medical devices
General understanding of the product development process and design controls
Ability to manage several projects simultaneously
Strong interpersonal and influencing skills
Ability to independently manage projects, prioritize time and communicate effectively
Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship.

Responsibilities

Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.
Develops and executes regulatory strategies for new and modified products.
Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.
Manages the release and shipment of products under regulatory controls to all regions.
Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.
Coordinates and prepares regulatory submissions for new and modified products ensuring compliance with applicable regulatory requirements and company policies.
Handles the preparation and processing of documentation required for new product introductions and revised products in international markets.
Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
Provides technical guidance and regulatory training to cross-functional teams.
Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.
Monitor the development of new regulatory requirements and advise of the impact to cross-functional teams.
Develops and maintains procedures to ensure compliance and support business goals.
Maintains proficiency in government regulations and guidances.
Support other regulatory requests or projects as needed.