Regulatory Affairs Specialist I

MaineGuide; Portland (ME); Sur place; USD 28 000 - 34 000; Plein temps

Résumé du poste

Viltis seeks an early‑career Regulatory Affairs Specialist I to support regulatory submissions and product registrations for IVD diagnostics. The role focuses on domestic and international submissions, change control, and quality documentation within a leading diagnostics organization in South Portland, Maine.

The ideal candidate has a science/engineering background, strong organization, and ability to work across cross‑functional teams to ensure regulatory compliance and timely approvals for

Qualifications

• Bachelor's degree and relevant science/engineering background required.
• Strong written and verbal communication skills, plus attention to detail.
• Experience with regulatory affairs or QA/manufacturing environment is a plus.

Responsabilités

• Prepare and maintain documentation for domestic and international regulatory submissions and registrations.
• Evaluate changes and support change control and labeling/documentation upkeep.
• Maintain regulatory databases and ensure compliance with FDA/ISO quality systems.

Connaissances

Regulatory submissions

Documentation management

FDA regulations

Cross-functional collaboration

Formation

Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, Immunology, Medical Technology, Engineering

Outils

Microsoft Office

Description du poste

Regulatory Affairs Specialist I

Location: South Portland, ME 04106 (65 Gannett Drive)
Job Type: Full-Time Contract
Schedule: Monday–Friday | 40 Hours per Week
Start Date: November 2, 2026
Industry: Medical Devices / In Vitro Diagnostics (IVD)
Experience Level: Entry-Level | 0–2 Years

Position Overview

Viltis is seeking a detail-oriented Regulatory Affairs Specialist I to support a leading global diagnostics organization in South Portland, Maine.

This position supports the Infectious Disease business unit, focusing on domestic and international regulatory submissions, product registrations, regulatory compliance, and quality management activities for in vitro diagnostic (IVD) products.

The ideal candidate has a scientific or technical educational background, strong organizational skills, and an interest in regulatory affairs within the medical device and diagnostics industry.

This is an excellent opportunity for an early-career professional looking to develop regulatory expertise while supporting products that play a critical role in infectious disease detection and patient care.

Key Responsibilities

Regulatory Submissions & Product Registrations

• Prepare, compile, and maintain documentation for domestic and international regulatory submissions, product registrations, license renewals, and annual registrations.
• Research scientific and regulatory information to support regulatory submissions and technical documentation.
• Maintain existing product approvals, licenses, and marketing authorizations.
• Support U.S. regulatory submissions and international registration documentation.
• Maintain accurate information in global regulatory databases and tracking systems.

Regulatory Compliance & Change Control

• Evaluate product, manufacturing, and labeling changes to determine regulatory reporting requirements.
• Support day-to-day manufacturing and operations activities involving change control.
• Assist in maintaining regulatory compliance for product labeling, documentation, and distribution.
• Interpret applicable regulatory requirements and provide guidance to cross‑functional teams.
• Monitor changes in global regulatory requirements affecting IVD and diagnostic products.

Quality Systems & Documentation

• Support compliance with FDA regulations, ISO standards, and applicable quality management systems.
• Maintain organized electronic and physical regulatory documentation.
• Assist in developing and improving internal regulatory procedures, processes, and tracking tools.
• Collaborate with Quality Assurance, Manufacturing, Product Development, and Regulatory Affairs teams.
• Ensure activities comply with established company policies, procedures, and quality standards.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, Immunology, Medical Technology, Engineering, or a related scientific or technical discipline, or an equivalent combination of education and experience.
• 0–2 years of experience in regulatory affairs or a related scientific, quality assurance, manufacturing, or product development environment.
• Basic understanding of FDA regulations and quality management principles.
• Strong written and verbal communication skills.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities and meet deadlines.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• Ability to work independently and collaboratively within cross‑functional teams.

Preferred Qualifications

• Previous experience in the medical device, biotechnology, pharmaceutical, or diagnostics industry.
• Familiarity with in vitro diagnostic (IVD) products or biologics.
• Knowledge of FDA medical device regulations and ISO 13485 quality management systems.
• Experience supporting regulatory submissions, product registrations, or change control activities.
• Familiarity with regulatory documentation systems and databases.
• Experience with document control, product labeling, or quality system compliance.
• Internship or academic experience involving regulatory affairs, quality assurance, or regulated laboratory operations.

Ideal Candidate

We encourage applications from recent science and engineering graduates and early‑career professionals with experience in:

• Regulatory Affairs or Regulatory Compliance
• Quality Assurance / Quality Control
• Medical Device or IVD Manufacturing
• Document Control and Change Management
• Scientific Affairs or Product Development
• Biotechnology or Diagnostic Laboratory Operations

Why Join Viltis?

At Viltis, we connect talented professionals with opportunities at leading organizations across the medical device, biotechnology, pharmaceutical, and life sciences industries.

This opportunity offers valuable exposure to global regulatory operations, FDA compliance, and quality systems while supporting innovative infectious disease diagnostic technologies.

Viltis is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other status protected by applicable law.

Pay: $20.00 - $25.00 per hour

Expected hours: 40.0 per week

Work Location: In person