Global Regulatory Affairs Specialist: Submissions & Compliance

Maine Tech Hub; Portland (ME); On-site; USD 75,000 - 95,000; Full time

Job summary

Spectraforce Technologies Inc. in South Portland, Maine is seeking a Regulatory Affairs Specialist I to support domestic and international product registrations within the Infectious Disease unit.

You will compile and publish submission material, maintain licenses, review changes for regulatory impact, and help develop internal procedures. A BS in a technical field is preferred and 0–2 years of regulatory or related experience is expected.

Qualifications

• Knowledge of Federal Regulations
• Demonstrated written and verbal communication skills
• Strong time management skills, with the ability to work on multiple projects simultaneously
• Ability to work independently as well as within a team
• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
• Quality Management System per ISO, FDA, and other regulatory agencies
• Experience: 0-2 years regulatory experience and/or relevant industrial experience
• Knowledge of regulations and standards affecting IVDs and/or biologics
• BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Responsibilities

• Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation, labeling, field support.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

Skills

Regulatory knowledge

Communication skills

Time management

Independent work

MS Office suite

QMS knowledge (ISO/FDA)

Education

Bachelor's degree in biology/chemistry/biochemistry/engineering

Tools

MS Office Suite

Visio

Job description

Spectraforce Technologies Inc. in South Portland, Maine is seeking a Regulatory Affairs Specialist I to support domestic and international product registrations within the Infectious Disease unit.

You will compile and publish submission material, maintain licenses, review changes for regulatory impact, and help develop internal procedures. A BS in a technical field is preferred and 0–2 years of regulatory or related experience is expected.