The Director of Regulatory Affairs will ensure product compliance with applicable regulations. They will also play a key role in implementing internal audits, overseeing compliance reports, and developing regulatory processes while staying informed of regulatory changes and their impact on the business is essential to the role.

Duties and Responsibilities:
 

• Develop and execute regulatory strategies for new and existing medical devices to ensure compliance with global regulatory requirements (FDA, EMA, MDR, etc.).
• Monitor regulatory changes and update internal teams regarding potential impacts on product development and market access.
• Provide regulatory guidance to cross-functional teams throughout the product lifecycle, including during design, development, and post-market phases.
• Generate regulatory communications and determine when incidents require reporting to regulatory authorities.
• Oversee and guide the goals and objectives of the Regulatory Affairs (RA) team.
• Lead, mentor, and develop a team of regulatory professionals to ensure effective execution of regulatory strategies.
• M aintain all necessary product documentation and technical records as required by regulations.
• Provide training and coaching to internal teams on regulatory affairs processes, requirements, and best practices.
• Conduct internal audits and ensure compliance with relevant regulations.
• Conduct research to support regulatory submissions and ensure the organization is compliant with evolving regulatory standards.
• Communicate technical regulatory updates and their impact to non-technical staff and leadership.
   

Qualifications:
 

• Bachelor’s degree in a scientific, engineering, or healthcare-related field.
• Minimum of 7 years' experience in an ISO13485, FDA, and EU regulated environment.
• Experience in manufacturing or quality assurance in an FDA-regulated setting, with a in-depth understanding of cGMP, QSR, MDR, and ISO13485 standards.
• Proven experience with 510(k) submissions and international regulatory requirements (CE marking, EU MDR, etc.).
• Comprehensive knowledge of domestic and international regulations.
• Excellent leadership and project management skills.
• Strong interpersonal and communication skills to effectively interact with regulatory authorities, internal teams, and stakeholders.