Regulatory Affairs Associate - Medical Devices / IVDR

Job Description

Job Description

Regulatory Affairs Associate – Medical Devices / IVDR

Location: South Portland, ME
Schedule: Monday–Friday, 7:00 AM–4:30 PM
Pay Range: $20.00–$23.00 per hour
Employment Type: Full-Time Contract
Contract Duration: 12 Months, with possibility of extension
Industry: Medical Devices / Diagnostics

About the Opportunity

Viltis is seeking a Regulatory Affairs Associate to support our client, a leading organization within the medical device and diagnostics industry, at their South Portland, Maine location.

This is an entry-level/early-career Regulatory Affairs opportunity supporting the IVDR (In Vitro Diagnostic Regulation) group . The Regulatory Affairs Associate will assist with regulatory documentation, product registrations, submissions, tracking, and post-market activities throughout the product lifecycle.

This position is well suited for a detail-oriented professional with at least 1 year of relevant experience who is interested in building a career in Regulatory Affairs within the medical device and diagnostics industry.

Key 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.

Qualifications

Required

• 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.

Preferred

• Associate's or Bachelor's degree in Biology, Chemistry, Life Sciences, Biomedical Sciences, Regulatory Affairs, Engineering , or a related field.
• Previous experience in Regulatory Affairs, Quality Assurance, regulatory documentation, compliance, medical devices, diagnostics, pharmaceuticals, biotechnology, or another regulated industry .
• Exposure to IVD products, IVDR, FDA regulations, ISO standards, or medical device regulatory requirements .
• Experience working with SOPs, controlled documentation, technical documentation, quality systems, or regulatory submissions.

Ideal Candidate

The ideal candidate is an early-career professional with at least 1 year of relevant experience who wants to develop a career in Regulatory Affairs.

Candidates with direct Regulatory Affairs experience are highly desirable; however, individuals with relevant experience in Quality Assurance, life sciences, laboratory operations, compliance, technical documentation, medical devices, diagnostics, or another regulated environment may also be a strong fit.

Successful candidates will be highly organized, detail-oriented, comfortable working with technical documentation, and able to learn regulatory processes quickly.