IVDR Regulatory Affairs Associate | Medical Devices

Viltis; Portland (ME); Vor Ort; USD 28.000 - 32.000; Vollzeit

Zusammenfassung

Viltis is seeking a Regulatory Affairs Associate to support regulatory documentation, product registrations, and submissions for IVDR within the medical device and diagnostics sector at our South Portland, ME location. This entry-level/early-career role provides exposure to regulatory tracking, post-market activities, and collaboration with Quality, R&D, Marketing, and other teams.

The position is a 12-month full-time contract with a Monday–Friday schedule and a pay range of $20.00–$23.00 per

Qualifikationen

• 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 learn and apply regulatory requirements and internal procedures.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Organizational skills

Time management

Written and verbal communication

MS Office proficiency

Independent work

Cross-functional collaboration

Ausbildung

High school diploma or equivalent

Bachelor’s degree in Biology, Chemistry, Life Sciences, Biomedical Sciences, Regulatory Affairs, Engineering

Tools

Microsoft Office

Jobbeschreibung

Viltis is seeking a Regulatory Affairs Associate to support regulatory documentation, product registrations, and submissions for IVDR within the medical device and diagnostics sector at our South Portland, ME location. This entry-level/early-career role provides exposure to regulatory tracking, post-market activities, and collaboration with Quality, R&D, Marketing, and other teams.

The position is a 12-month full-time contract with a Monday–Friday schedule and a pay range of $20.00–$23.00 per