Regulatory Affairs Specialist – IVDR for EU Diagnostics

GForce Life Sciences; South Portland (ME); On-site; USD 75,000 - 95,000; Full time

Job summary

A life sciences company in South Portland, Maine is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. The ideal candidate will have at least 4 years' experience in Regulatory Affairs and a strong understanding of IVDR and EU regulations. Key responsibilities include developing regulatory strategies for product clearance and providing support for commercial diagnostic products. The role demands excellent communication skills and proficiency in Microsoft Office.

Qualifications

• 4+ years’ experience in Regulatory Affairs role.
• Strong knowledge of IVDR and EU regulatory requirements is required.

Responsibilities

• Prepare documentation for EU Technical Files and international product registrations.
• Responsible for technical writing of files in accordance with IVDR.
• Develop regulatory strategies for products to achieve clearance/approval.

Skills

Technical writing

Regulatory knowledge

Communication skills

Time management

Microsoft Office proficiency

Education

Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or related technical field

Tools

Microsoft Office

Job description

A life sciences company in South Portland, Maine is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. The ideal candidate will have at least 4 years' experience in Regulatory Affairs and a strong understanding of IVDR and EU regulations. Key responsibilities include developing regulatory strategies for product clearance and providing support for commercial diagnostic products. The role demands excellent communication skills and proficiency in Microsoft Office.