Regulatory Affairs Associate: Med Devices & IVD Submissions

Viltis; South Portland (ME); On-site; USD 28,000 - 32,000; Full time

Job summary

Viltis is seeking a Regulatory Affairs Associate in South Portland, ME to support regulatory submissions and registrations for medical devices and diagnostics. This contract role partners with cross-functional teams to ensure compliance and timely submissions.

The ideal candidate will have at least 1 year of experience, strong attention to detail, and proficiency with Microsoft Office. Location is on-site in South Portland, with a Monday–Friday schedule.

Qualifications

• High school diploma or equivalent required.
• Minimum 1 year of relevant work experience.
• Strong attention to detail with the ability to accurately prepare, review, and maintain documentation.
• Strong organizational and time-management skills.
• Effective written and verbal communication skills.
• Ability to manage multiple assignments and priorities in a deadline-driven environment.
• Ability to learn and apply regulatory requirements and internal procedures.
• Proficiency with standard Microsoft Office applications.
• Ability to work independently while collaborating effectively with cross-functional teams.

Responsibilities

• Assist with the preparation, organization, and maintenance of regulatory submissions and registration packages.
• Support regulatory activities for in vitro diagnostic (IVD) and medical device products.
• Compile and organize materials for pre-submission reports and registration activities.
• Coordinate registration requests and track progress through completion.
• Assist with product registration submissions, amendments, supplements, reports, and other regulatory documentation.
• Maintain global product listings, facility registrations, licenses, approvals, and annual registrations.
• Support the preparation of routine regulatory reports and communications with regulatory agencies.
• Assist with post-market regulatory reports and submissions.
• Maintain accurate electronic and paper regulatory documentation and archival systems.
• Perform quality-control reviews of regulatory documents and submission materials.
• Research regulatory requirements, submission requirements, and regulatory histories of similar products.
• Assist with monitoring project timelines and maintaining regulatory tracking and control systems.
• Support the development, review, and maintenance of Standard Operating Procedures (SOPs).
• Monitor changes in applicable regulatory requirements and procedures.
• Assist with documentation related to import/export activities, registrations, tenders, and bids as needed.
• Collaborate with Regulatory Affairs, Quality, Research & Development, Marketing, and other cross-functional teams.
• Support regulatory activities associated with manufacturing changes, product line extensions, technical labeling, and continued product approvals.
• Participate in regulatory strategy, risk management, and other product lifecycle activities as assigned.

Skills

Attention to detail

Organizational skills

Time-management

Written and verbal communication

Education

High school diploma

Associate or Bachelor's degree in Life Sciences

Tools

Microsoft Office

Job description

Viltis is seeking a Regulatory Affairs Associate in South Portland, ME to support regulatory submissions and registrations for medical devices and diagnostics. This contract role partners with cross-functional teams to ensure compliance and timely submissions.

The ideal candidate will have at least 1 year of experience, strong attention to detail, and proficiency with Microsoft Office. Location is on-site in South Portland, with a Monday–Friday schedule.