Regulatory Affairs Associate (IVDR)

Location: South Portland, Maine; Monday–Friday, 7:00 AM–4:30 PM

Salary: $20.00–$23.00 per hour

Company

Recruiting support is provided for a client operating in the medical device and diagnostics industry.

What you will do

• Prepare, organize, maintain, and quality-check regulatory submissions, registration packages, reports, and related documentation.
• Support regulatory activities for in vitro diagnostic and medical device products, including IVDR activities.
• Coordinate registration requests and track submissions, approvals, licenses, listings, and annual registrations through completion.
• Maintain regulatory documentation, archival systems, tracking tools, SOPs, and product lifecycle records.
• Research regulatory requirements, monitor changes, and support post-market reports, manufacturing changes, labeling, and continued product approvals.
• Collaborate with Regulatory Affairs, Quality, Research & Development, Marketing, and other cross-functional teams.

Requirements

• High school diploma or equivalent.
• At least 1 year of relevant work experience.
• Strong attention to detail, organization, time management, and written and verbal communication skills.
• Ability to manage multiple priorities in a deadline-driven environment and work independently with cross-functional teams.
• Ability to learn and apply regulatory requirements and internal procedures.
• Proficiency with standard Microsoft Office applications.

Nice to have

• Associate's or bachelor's degree in biology, chemistry, life sciences, biomedical sciences, regulatory affairs, engineering, or a related field.
• Experience in Regulatory Affairs, Quality Assurance, compliance, technical documentation, medical devices, diagnostics, pharmaceuticals, biotechnology, or another regulated industry.
• Exposure to IVD products, IVDR, FDA regulations, ISO standards, quality systems, SOPs, or regulatory submissions.

Culture & Benefits

• Full-time contract position for 12 months.
• Potential contract extension based on business needs and performance.
• Hands-on experience with Regulatory Affairs and IVDR activities in the medical device and diagnostics industry.
• Regular weekday schedule with daytime working hours.