Senior Regulatory Affairs Specialist

We are seeking an experienced Senior Regulatory Affairs Specialist to support our growing Regulatory Affairs organization. This is a high-impact individual contributor role for a regulatory professional who can independently manage core regulatory activities, own moderately complex U.S. and international submissions, and provide strong cross-functional support across product development and sustaining activities.

What You Will Do

Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables. Support the development and continuous improvement of regulatory processes, systems, templates, and documentation practices to help scale the Regulatory Affairs function as the company grows.

Why It Might Be a Fit

The ideal candidate brings solid FDA experience, working knowledge of global regulatory landscapes, and a proactive, collaborative mindset to navigating evolving regulatory requirements. As a member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market.

Requirements

• Master's degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry
• Prior experience with the FDA and/or other regulatory agencies is required
• Proven success owning regulatory submissions such as 510(k)s and letters to file and supporting regulatory strategy through product development lifecycles
• Experience providing regulatory guidance in areas such as biocompatibility, packaging, sterilization, labeling, and review of product claims and promotional content in a fast-paced, innovative environment
• Strong understanding of U.S. regulatory requirements; familiarity with EU MDR and other international regulations preferred
• U.S. and/or European/International regulations and standards knowledge is required
• Demonstrated ability to work effectively with cross-functional teams, with strong technical writing, organizational, and communication skills
• Proven analytical capabilities, solid understanding of manufacturing, change control, and awareness of regulatory industry trends
• Effective communicator and relationship-builder with cross-functional stakeholders and external regulators
• Bachelor's degree in Life Sciences, Engineering, or related field required; advanced degree and/or RAC certification preferred

Benefits

• Competitive base salary of $145,000 - $160,000
• Variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation