Regulatory Affairs Associate - IVDR (Entry Level)

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

Job summary

Viltis is seeking an entry-level Regulatory Affairs Associate to support an IVDR group for a leading medical devices/diagnostics organization in South Portland, Maine.

You will help with regulatory documentation, registrations, submissions, and lifecycle activities, working across Regulatory Affairs, Quality, R&D, Marketing, and other teams.

Ideal candidates have at least 1 year of relevant experience and a detail-oriented, collaborative mindset, with willingness to learn regulatory requirements.

Qualifications

• 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.
• 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

Communication skills

Microsoft Office

Education

Biology/Life Sciences degree

Tools

Microsoft Office Suite

Job description

Viltis is seeking an entry-level Regulatory Affairs Associate to support an IVDR group for a leading medical devices/diagnostics organization in South Portland, Maine.

You will help with regulatory documentation, registrations, submissions, and lifecycle activities, working across Regulatory Affairs, Quality, R&D, Marketing, and other teams.

Ideal candidates have at least 1 year of relevant experience and a detail-oriented, collaborative mindset, with willingness to learn regulatory requirements.