Asensus has a unique opportunity for a Regulatory Affairs Specialist to join our team and help bring an innovative digital surgery product to market. The Regulatory Affairs Specialist supports regulatory pre-market and post-market objectives for Asensus medical device marketing. They will help in the preparation and submission of an FDA premarket 510(k) as well as international product registrations.

At Asensus, we are digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus looking for a fulfilling career, and that's exactly what they find.

What You Bring

• A minimum of 3 years of medical device regulatory affairs experience/ 4-6 years of regulatory affairs experience is preferred
• Solid knowledge of US FDA regulations and Quality System regulations
• A successful track record in preparing submissions for Class II medical devices is preferred. 
• Experience with Pre-submission, technical files, and international product registrations
• Experience interacting with US FDA is preferred

What We Offer 

• A culture driven to achieve our mission and deliver remarkable results
• Coworkers committed to collaboration and winning the right way
• Quality products that improve the lives of our customers and patients
• Ability to discover your strengths, follow your passion and find your own rewarding career
• A Flexible, engaging work environment
• A competitive benefits package

At Asensus, we believe in contributing to a society that welcomes diverse voices and values differences in lived experiences, culture, religion, age, gender identity, sexual orientation, race, ethnicity, and neurodiversity. We are committed to ensuring this same environment for our employees – a culture where individuals feel safe, heard, and respected. We celebrate the uniqueness of our global workforce and know that only through inclusion, ongoing learning, and partnership can we succeed. Together we are all stronger.

• A minimum of 3 years of medical device regulatory affairs experience/ 4-6 years of regulatory affairs experience is preferred
• Solid knowledge of US FDA regulations and Quality System regulations
• A successful track record in preparing submissions for Class II medical devices is preferred. 
• Experience with Pre-submission, technical files, and international product registrations
• Experience interacting with US FDA is preferred