Senior Regulatory Affairs Specialist

Who We Are

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.

What You'll Do

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:

We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for enabling technologies in the orthopedic industry. This role will be working on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist. This role will develop and champion regulatory strategies, work within cross-functional teams, liaise with regulatory authorities to support the initial launch of medical devices. This role will also facilitate regulatory strategies which support use of machine learning and artificial intelligence within enabling technology products portfolio. 

The Senior RA Specialist is responsible for managing regulatory activities within the United States, European Union and Australian markets. This role ensures compliance with Therapeutic Goods Administration (TGA) regulations, EU MDR ISO 13485, ISO 14971, 21 CFR 820 and company-wide quality standards. Working as part of a global RA function, the role will also support in sustainable regulatory activities such as management of post market surveillance activities on behalf of legal manufacturers, completing re