Asensus is currently seeking a Global Head of Regulatory and Quality to join our growing. You will be responsible for pre- and post-market compliance to mostly US and also international regulations. This position is responsible for developing global regulatory and quality strategies for surgical robotic medical devices. 

The individual will be mainly focused on US Regulatory management and will plan, prepare, and coordinate submissions of FDA premarket 510(k) submission. This role is expected to have deep product and US FDA regulatory knowledge and will provide regulatory leadership on project teams as needed, as well as mentoring the work of other Managers on the Regulatory team.

Regulatory duties also include development and implementation of regulatory policy for compliance, participation to internal and external audits, supervision of labeling and promotions, and exporting. 

This position is also responsible for supervision of the Company’s quality system. 

This position serves as the Company’s management representative to regulatory authorities for the quality system and as the Company’s primary liaison during US regulatory inspections.

Who We Are

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’ll Do 

• Develops best practices for Regulatory Affairs processes
• Acts as the FDA Official Correspondent for establishment registration and listing 
• Responsible for managing the global QA/RA budget
• Supervises, authors, prepares, and submits Premarket 510(k) submissions to US FDA for medical devices
• Partners with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning for 510(k) submissions
• Engages FDA regulators, verbally and through written communications to discuss pending or new submissions, regulatory requirements, etc.
• Supervises and supports RA Manager in the development of on-product labeling; advises and approves advertising and promotional materials in accordance with regulations and device-specific regulatory clearances/approvals
• Interprets regulations and provides regulatory guidance to global teams
• Advises on US regulatory assessments for adverse events and change orders
• Global Quality Systems supervision
• Develop and implement policies and procedures for Company compliance for quality assurance, regulatory compliance, and regulatory market clearance to requirements such as IDE and 510(k) regulations, ISO 13485, EU’s Medical Device Directive & Medical Device Regulation, Quality System Regulation 21 CFR Part 820, GLP regulations, and clinical regulations including ISO 14155 and 21 CFR Parts 50, 54, 56, 812, and HIPAA. May include other international regulations as applicable.
• Provides QA/RA support during internal and external audits
• Part 11 electronic records and signatures program development, maintenance and compliance.
• All Other Essential Duties as directed

What You Bring 

• Requires a bachelor's degree in a related technical field and at least 15+ years of experience in the field.
• Minimum 10+ years experience leading, managing and developing teams
• Deep knowledge of US FDA regulations
• Proven experience with 510k submissions
• Familiar with a variety of the field's concepts, practices, procedures and regulations.
• Familiarity and operating experience in a global setting, US, Europe and Asia .

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
• Flexible, engaging work environment
• A competitive benefits package

• Requires a bachelor's degree in a related technical field and at least 15+ years of experience in the field.
• Minimum 10+ years experience leading, managing and developing teams
• Deep knowledge of US FDA regulations
• Proven experience with 510k submissions
• Familiar with a variety of the field's concepts, practices, procedures and regulations.
• Familiarity and operating experience in a global setting, US, Europe and Asia.