Quality Assurance Assistant

Regulatory and Product Support Assistant

Location: Hybrid - need to be able to attend Cambridge siteHours: 37.5 hours per weekSalary: Competitive and will depend on experience

Reed Scientific have partnered with an industry leading Biotech at the forefront of diabetes research. My client has an immediate requirement for someone to support the regulatory and product compliance functions. You will manage documentation, assist with regulatory submissions, and perform administrative tasks to ensure smooth operations including maintaining compliance with relevant regulations and support product-related activities.

Key Responsibilities

• Regulatory Support:
  • Prepare and submit regulatory documents, including applications, registrations, and reports, and maintaining an organized and up-to-date database of regulatory documents, approvals, and correspondence.
• Administrative Tasks:
  • Draft and format regulatory documents, letters, and other correspondence.
• Product Support:
  • Provide technical support to external partners and customers by responding to inquiries or complaints in line with regulatory guidelines.

Qualifications and Experience

• Bachelor's degree in a Life Science related field
• 2 years of experience in a regulatory, compliance, or product support environment, with a basic understanding of regulatory requirements for medical device software development (e.g., ISO 13485).
• Strong organizational skills and attention to detail.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management systems.
• Excellent communication skills, both written and verbal.

If you are passionate about making a difference in the field of diabetes management and meet the qualifications, please follow the link to apply.