Senior Regulatory Affairs Specialist, Medical Devices
Location: Palm Beach Gardens, Florida
Type: Full Time
Required Education: 4 Year Degree
Salary: Commensurate with experience
Submission & Registration
US Regulatory Affairs
Internal Number: SRAS1
Seeking Senior Regulatory Affairs Specialist with Duties and Responsibilities as follows:
Develop US (and potentially EU) regulatory strategy and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable.
Advise and provide regulatory direction to assigned Product Development Team(s) on the regulatory requirements, documentation, and testing needed for FDA (and potentially EU) regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
Prepare, write, and submit FDA (and potentially EU) submissions for new products and product changes as required in accordance with established time-lines and submission dates to ensure timely approvals while in compliance with regulations.
Team with internal Regulatory Affairs colleagues responsible for international product registrations to provide regulatory support for new products and changes to existing products.
Provide business and product information to internal Regulatory Affairs colleagues responsible for international product registrations to enable development of strategies and communicate that information to assigned Product Development Team(s).
Review and approve design control documentation, engineering change orders for design, manufacturing, and labeling changes to ensure compliance with global regulations.
Provide feedback and on-going support to Product Development Team(s) to resolve (potential) regulatory issues and questions from regulatory agencies.
Rigorously review regulatory documentation to ensure completeness, clarity, consistency, and conformance to regulations and guidelines.
Coordinate and consult with Regulatory Director and/or other departments on the content and review of regulatory documentation.
Provide support to currently-marketed products as necessary. This includes: reviewing labeling, reviewing promotional material, reviewing product changes, preparing documentation for changes requiring government approval, and preparing submissions and reports for regulatory agencies as required by product status.
Interact directly with FDA (and possibly Notified Body) on projects/products at reviewer level.
Establish, develop, and maintain positive relationships with regulatory agency personnel.
Maintain proficiency in applicable regulatory requirements.
4-7 years relevant experience required, preferably in a Regulatory Affairs role in the medical device industry.
Bachelor’s degree required. Engineering or science discipline preferred.
Experience authoring and submitting medical device registrations/submissions for US Class II devices.
Experience with implant devices and/or with medical devices incorporating software preferred.
Experience reviewing product labeling and advertising/promotional material for medical devices preferred.
Experience with EU Medical Device Regulations preferred.
Integrity Implants Inc. d/b/a Accelus is committed to accelerating minimally invasive spine surgery through its enabling technology with broad accessibility to previously underserved markets. Established in 2021 through the combination of Integrity Implants and Fusion Robotics, the company is focused on providing its proprietary Adaptive Geometry implant technology with pragmatic and economical navigation and robotic solutions with broad clinical use in spine surgery. Learn more at www.accelusinc.com.