Contract Regulatory Affairs Associate, Medical Devices

Akkodis; Portland (ME); On-site; USD 23,000 - 32,000; Full time

Job summary

Akkodis is seeking a Regulatory Affairs Associate for a contract role based in Portland, ME. The role focuses on supporting global medical device registrations and maintaining regulatory documentation throughout the product lifecycle.

The candidate will prepare submissions, monitor regulatory changes, and collaborate with R&D, Quality, Manufacturing, and Marketing to ensure timely approvals and ongoing compliance across markets.

Qualifications

• Experience in Medical Device Regulatory Affairs.
• Knowledge of global regulatory requirements and submission processes.
• Strong documentation, project coordination, and stakeholder management skills.
• Ability to work independently and manage multiple regulatory activities simultaneously.

Responsibilities

• Prepare regulatory submissions, registrations, amendments, and reports.
• Support pre-market and post-market regulatory activities for medical devices.
• Monitor global regulatory changes and assess business impact.
• Maintain product registrations, licenses, approvals, and facility registrations.
• Collaborate with internal stakeholders on regulatory strategy, product changes, labeling, and compliance requirements.
• Support SOP development and regulatory process improvements.
• Ensure accuracy, quality, and completeness of regulatory documentation.
• Act as a regulatory representative throughout the product lifecycle.

Skills

Regulatory affairs

Project coordination

Stakeholder management

Documentation management

Regulatory submissions

Education

Technical Diploma

Job description

Akkodis is seeking a Regulatory Affairs Associate for a contract role based in Portland, ME. The role focuses on supporting global medical device registrations and maintaining regulatory documentation throughout the product lifecycle.

The candidate will prepare submissions, monitor regulatory changes, and collaborate with R&D, Quality, Manufacturing, and Marketing to ensure timely approvals and ongoing compliance across markets.