IVDR Regulatory Specialist II: EU Submissions & Strategy

Planet Pharma; South Portland (ME); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. Applicants should possess a Bachelor's degree in a related technical field and have over 4 years of experience in Regulatory Affairs, particularly with IVDR and EU regulations. Key responsibilities include providing regulatory support for product development, compiling submission documents, and maintaining approvals for marketing authorizations. This role emphasizes strong communication and time management skills.

Qualifications

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

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 in the EU.

Skills

Knowledge of IVDR

Written communication skills

Verbal communication skills

Time management skills

Ability to work independently

Ability to work within a team

Education

Bachelors Degree in Biology, Chemistry, Biochemistry, Engineering or related field

Tools

Microsoft Office (Word, Excel, PowerPoint, Visio)

Job description

A leading pharmaceutical company is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. Applicants should possess a Bachelor's degree in a related technical field and have over 4 years of experience in Regulatory Affairs, particularly with IVDR and EU regulations. Key responsibilities include providing regulatory support for product development, compiling submission documents, and maintaining approvals for marketing authorizations. This role emphasizes strong communication and time management skills.