Regulatory Affairs Medical Devices

G&L are searching for a Med Devices specialist for a 6 month contract for a role within our CMC Regulatory Affairs Devices team. This position will focus on providing regulatory expertise for medical devices and combination products. The position involves developing and reviewing Design History Files and Technical Files, guiding regulatory strategies, and ensuring compliance with the major territories of US FDA and EU EMA.

Key Responsibilities:

• Prepare and review Design History and Technical Files for combination and standalone devices.
• Plan and manage submissions to regulatory bodies and notified bodies.
• Provide regulatory guidance to CMC and technical teams.
• Support lifecycle management and change strategies for medical devices and combination products.

Skills and Qualifications:

• Experience in medical device or combination product regulatory affairs.
• Strong communication, teamwork, and problem-solving skills.
• Attention to detail and effective time management.
• Proficiency in Word, Excel, and document management systems.
• Degree in Engineering, Pharmacy, Chemistry, or related discipline.

Preferred Experience:

• Global regulatory experience with a specific focus on US/ EU requirements.
• Hands-on involvement with Design History and Technical Files.
• Understanding of lifecycle impacts on regulatory submissions.
• Understanding of the operation of Veeva Vault document management system