Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Onsite

Endofix Medical is a small, innovative medical device company developing advanced endoscopic surgical devices. We are seeking an experienced and highly motivated Senior Regulatory Affairs Specialist to lead regulatory activities and provide strategic guidance across the product lifecycle.

This is an excellent opportunity for a regulatory professional who enjoys working in an entrepreneurial environment and wants to have a meaningful impact on the development, commercialization, and ongoing compliance of innovative medical devices.

• Develop and implement regulatory strategies for new and existing medical devices.
• Provide regulatory guidance throughout the product lifecycle, including product development, design changes, manufacturing, labeling, and commercialization.
• Lead and support regulatory submissions, including 510(k) s for Class II medical devices, as well as associated technical and regulatory documentation.
• Evaluate proposed product and process changes and determine appropriate regulatory pathways and requirements.
• Partner with product development, engineering, quality, manufacturing, and commercial teams to ensure regulatory requirements are incorporated into projects and business activities.
• Interface with external Contract Manufacturing Organizations (CMOs) and other partners to obtain and evaluate documentation required for regulatory activities and submissions.
• Serve as the regulatory subject matter expert on cross-functional teams and provide clear, practical regulatory guidance.
• Support compliance of product labeling, promotional materials, and advertising with applicable regulatory requirements.
• Interact with regulatory agencies, including the FDA and European Notified Bodies, as appropriate, to support product clearances, approvals, and ongoing regulatory activities.
• Monitor changes in applicable regulations, guidance documents, and standards and assess their impact on the company's products and operations.
• Maintain regulatory documentation and support ongoing regulatory compliance activities for existing products.
• Work independently while effectively managing multiple projects and priorities in a fast-paced, entrepreneurial environment.

• Bachelor's degree or higher in Science, Engineering, Regulatory Affairs, or a related technical field.
• 5+ years of experience in medical device regulatory affairs
  , with demonstrated experience supporting or leading regulatory activities for Class II medical devices.
• Prior successful experience with 510(k) submissions is required.
• Working knowledge of applicable medical device regulations and standards, including FDA requirements, ISO 13485, EU MDR, and GMP/QMS requirements
  .
• Strong understanding of regulatory strategy and the ability to translate regulatory requirements into practical recommendations for cross-functional teams.
• Excellent written and verbal communication, interpersonal, and collaboration skills.
• Strong analytical and problem-solving abilities with exceptional attention to detail.
• Ability to manage multiple projects simultaneously, prioritize effectively, and meet deadlines.
• Demonstrated initiative and ability to work independently while also contributing effectively as part of a team.
• Experience working with external manufacturing or development partners is a plus.
• RAC certification is a plus.

This is an opportunity to join a growing medical device company where regulatory affairs is a highly visible and valued function. The successful candidate will have the opportunity to work closely with leadership and cross-functional teams and play an important role in bringing innovative endoscopic surgical technologies to market.