| Location | maine, ME |
Regulatory Affairs Specialist I - Infectious Disease Diagnostics
Job Location Type: In Person (Onsite)
Location: South Portland, ME 04106 (Supporting Scarborough, ME)
Job Type: 12-Month Contract
Shift Schedule: 1st Shift, Monday-Friday, 8:00 AM-4:30 PM
About the Role
We are seeking a detail-oriented Regulatory Affairs Specialist I to support regulatory submissions, product registrations, and compliance activities for infectious disease diagnostic products. This opportunity is ideal for an early-career professional with a background in biology, chemistry, microbiology, engineering, or another related technical field who is interested in building a career in regulatory affairs within the diagnostics industry.
Working with the Regulatory Affairs team, you will help prepare domestic and international regulatory documentation, maintain product registrations and authorizations, and assess product, manufacturing, and labeling changes for regulatory impact. You will also collaborate with Quality, Manufacturing, and Product Development teams to support compliance with applicable FDA regulations, ISO standards, and internal quality management procedures.
Candidates with 0-2 years of regulatory or relevant industry experience and strong documentation, communication, and organizational skills are encouraged to apply.
Key Responsibilities
Compile, prepare, and publish documentation required for regulatory submissions, product registrations, license renewals, and annual registrations.
Research scientific information and applicable regulatory requirements to support the preparation of submission documents.
Assist with U.S. regulatory submissions and international product registration documentation for relevant government agencies and regulatory authorities.
Maintain existing product approvals, licenses, registrations, and marketing authorizations.
Review product, manufacturing, and labeling changes to identify potential regulatory reporting requirements and compliance impacts.
Support manufacturing and operations teams with day-to-day change control activities and regulatory documentation.
Maintain accurate product information in the Global Regulatory Information Database and related tracking spreadsheets.
Support compliant product shipment by maintaining applicable regulatory approvals, product listings, and supporting documentation.
Organize and maintain electronic and hard-copy regulatory files, ensuring records are accurate and readily accessible.
Assist in developing and updating regulatory procedures, internal tools, and documentation practices.
Interpret applicable regulations and standards to support product development, manufacturing, labeling, and field support activities.
Collaborate with Regulatory Affairs, Quality, Manufacturing, and Product Development teams to resolve regulatory questions and maintain compliance.
Support the effectiveness of the Quality Management System in accordance with applicable FDA requirements, ISO standards, and internal procedures.
Stay informed about relevant domestic and international regulatory requirements affecting in vitro diagnostic (IVD) products and related technologies.
Required Qualifications
Bachelor's degree in Biology, Chemistry, Biochemistry, Microbiology, Engineering, or another related technical discipline, or an equivalent combination of education and experience.
0-2 years of regulatory affairs or relevant industry experience, including experience in quality, product development, product support, scientific affairs, or a related function.
Basic knowledge of federal regulations and regulatory compliance requirements.
Strong written and verbal communication skills, with the ability to prepare accurate documentation and communicate regulatory information clearly.
Excellent time management and organizational skills, with the ability to manage multiple assignments simultaneously.
Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Visio.
Ability to work independently under general guidance while collaborating effectively with cross-functional teams.
Strong attention to detail and commitment to maintaining accurate records and following established procedures.
Willingness to learn regulatory requirements and quality system processes for diagnostic products.
Preferred Qualifications
Knowledge of regulations and standards applicable to in vitro diagnostics (IVD), medical devices, and/or biologics.
Previous exposure to FDA requirements, ISO standards, or regulated quality management systems.
Experience supporting regulatory submissions, product registrations, license renewals, or regulatory documentation.
Familiarity with change control, product labeling reviews, manufacturing documentation, or product development support.
Experience maintaining regulatory databases, compliance trackers, spreadsheets, or electronic document repositories.
Academic or professional background in infectious disease diagnostics, immunology, medical technology, or laboratory sciences.
Strong analytical and problem-solving skills, with the ability to interpret technical and regulatory information.