ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com .
Responsibilities
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better. And that's how we create better together. Why work at Enovis? See for yourself .
As a key member of the Regulatory Affairs team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title:
Senior Regulatory Affairs Specialist
Reports To:
Regulatory Affairs Manager
Location:
Austin, TX
Job Title/High Level Position Summary :
Regulatory Affairs
Develop global regulatory strategies for new product development initiatives, identifying streamlined and least burdensome pathways for marketing authorization of new or modified products
Suggest and lead pre-submission meetings with FDA, Notified Body and TGA as determined to be necessary for select product development pathways
Partner closely with clinical affairs in development and execution of clinical strategy and necessary clinical investigations and evaluations related to achieving marketing authorizations
Execute regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, and Australia. This includes responding to requests from reviewers and resolving deficiencies in submissions.
Partnering with Corporate Market Access team to coordinate and support select international registrations and maintain existing licenses and certifications through renewals
Act as regulatory SME during technical documentation audits
Perform regulatory assessments on product or process changes and execute necessary actions such as appropriate notifications, new 510ks, letters to file, technical file updates, license amendments, etc.
Review and approve QMS change orders, design change orders, and NCRs, ensuring changes don't impact safety and effectiveness of products without appropriate regulatory actions being taken
Review labeling and marketing collateral to ensure compliance with regulations, approval conditions, and consistency of any claims with appropriate data
Own and manage specific regulatory-related CAPAs, driving root cause investigation, implementation of actions, and confirming effectiveness
Support completion of HHEs and work the Corporate Shared Services team to manage field actions and recalls
Monitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements; support initiatives associated with compliance with new or modified requirements
Enovis · Texas, Austin