Director, Regulatory Affairs – In Vitro Diagnostics Full Time

Job Responsibilities

• Develop regulatory submissions (510(k), IDE, PMA, IND, BLA) for IVD clients.
• Formulate and execute regulatory strategies.
• Manage analytical and clinical testing processes.
• Mentor and manage junior regulatory team members.
• Participate in business development activities.
• Interface directly with clients and regulatory bodies.
• Collaborate across MCRA departments for integrated project outcomes.
• Represent MCRA at industry conferences and meetings.

Required Qualifications

• Bachelor’s degree in a scientific discipline (Master’s or PhD preferred).
• 7+ years of Regulatory Affairs experience in medical devices.
• 3-4+ years of direct IVD device regulatory affairs experience.
• Expertise in FDA regulatory submissions and processes.
• Strong technical writing and analytical skills.
• Ability to lead projects and mentor junior staff.
• Experience with microbiology devices, companion diagnostics, or related fields.
• Proficiency in MS Office Suite and technical software.
• Excellent communication and presentation skills.
• Willingness to travel up to 10%.

Special Requirements

• Occasional travel to company offices and conferences.