Regulatory Affairs Manager

About Nyxoah:

Nyxoah is a medical technology company focused on improving the lives of people with obstructive sleep apnea (OSA) through the development and commercialization of the Genio® system. We operate in a dynamic, high-growth, highly regulated environment with teams across the U.S. and Europe. Our mission is to deliver safe, effective, patient-centered solutions through scientific rigor, innovation, and operational excellence.

Position Summary:

The Regulatory Affairs Manager is responsible for leading regulatory execution and managing regulatory staff to ensure timely and compliant submissions across US, EU, and international markets. This role serves as regulatory lead for assigned products, developing regulatory strategies, authoring and overseeing submissions, and guiding cross-functional teams through product development and post-approval activities.

Reporting to the Interim Head of Regulatory Affairs, this individual interacts directly with regulatory authorities and notified bodies, owns the regulatory intelligence process, and plays a key role in strengthening regulatory processes and maintaining ongoing compliance as the organization continues to grow.

Key Responsibilities:

• Directly manage regulatory team members, including setting priorities, reviewing work, and coordinating day-to-day regulatory activities.
• Lead regulatory strategy and execution for assigned products across US, EU, and international markets, including authoring and overseeing new product submissions, supplements, and post-approval filings.
• Establish and improve regulatory processes and systems, including leading remediation activities to maintain compliance.
• Define regulatory pathways for new and modified products and review and approve associated change documentation, labeling updates, and technical documentation revisions.
• Represent Regulatory Affairs in interactions with regulatory authorities, notified bodies, and international partners, including leading meetings and regulatory correspondence.
• Ensure maintenance of approved submissions and regulatory documentation, including renewals, annual reports, post-market reporting, and other ongoing compliance obligations.
• Own the regulatory intelligence process, ensuring new or changing regulatory requirements are assessed and communicated appropriately.
• Represent Regulatory Affairs during internal and external audits and inspections.

Core Competencies & Behaviors:

• Ownership & Accountability: Takes responsibility for outcomes and follows through consistently.
• Collaboration: Works effectively across functions, geographies, and levels.
• Adaptability: Responds constructively to change in a dynamic, scaling environment.
• Quality Focus: Demonstrates rigor, attention to detail, and commitment to high standards.
• Communication: Delivers clear, timely, appropriate information to key stakeholder/departments.
• Problem-Solving: Uses analytical, structured approaches to address issues.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related technical field
• 7–10 years of regulatory affairs experience supporting Class III and/or implantable medical devices
• Minimum 2 years of direct regulatory team management experience
• Demonstrated experience leading complex US, EU, and international regulatory submissions through approval
• Strong working knowledge of FDA regulations, EU MDR, and applicable global regulatory requirements
• Demonstrated ability to independently make regulatory decisions and guide cross-functional teams
• Experience working within an established Quality Management System (e.g., ISO 13485), including supporting design controls and change management activities
• Experience managing regulatory deliverables tied to fixed agency-driven timelines

Preferred Qualifications:

• Clinical regulatory experience, including IDE submissions, protocol amendments, and regulatory strategy for clinical investigations
• Experience in a startup or scaling medical device environment
• Experience leading or supporting regulatory audits and inspections, including preparation of documentation and response to findings
• Familiarity with additional global regulatory frameworks beyond US and EU (e.g., TGA, MedDO, Singapore HSA)

Compliance & Quality Expectations:

Ensures work complies with applicable regulatory requirements, industry standards, and Nyxoah’s internal quality system procedures. Maintains documentation and conduct in a manner consistent with inspection-ready expectations.

EEO Statement:

Nyxoah is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other protected status in accordance with applicable laws. All employment decisions are based on qualifications, merit, and business needs.