Regulatory Affairs Associate – Medical Devices / IVDR

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

Job summary

Bioethic Consulting LLC is seeking a Regulatory Affairs Associate in South Portland, ME. This entry‑level role supports IVDR activities and regulatory documentation for medical devices and diagnostics.

The position tasks include preparing submissions, tracking registrations, and maintaining records across the product lifecycle, with the team collaborating cross-functionally. Strong detail orientation and MS Office skills are essential.

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

Organization

Time management

Written and verbal communication

Multitasking

Regulatory requirements

Independent yet collaborative

Education

High school diploma

Associate's or Bachelor's degree in Biology, Chemistry, Life Sciences, Biomedical Sciences, Regulatory Affairs, Engineering

Tools

MS Office

Job description

Regulatory Affairs Associate – Medical Devices / IVDR
Quality South Portland , Maine Contract Sep 2, 2026

Regulatory Affairs Associate

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.

Location: South Portland, ME
Pay Range: $20.00–$23.00 per hour
Schedule: Monday–Friday, 7:00 AM–4:30 PM
Contract Duration: 12 months
Extension: Potential for extension based on business needs and performance

This is an excellent opportunity to gain hands-on experience supporting Regulatory Affairs and IVDR activities within the medical device and diagnostics industry while developing valuable experience in product registrations, regulatory documentation, submissions, and compliance.