Regulatory Affairs Associate

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 our Contract position with a direct client.

Position: Regulatory Affairs Associate

Location: Portland, ME

Duration: 12 months

Pay Range: $20/hr - $20/hour on W2 without benefits (Pay rate varies based on experience)

We are seeking an experienced Regulatory Affairs professional to support global medical device registrations and ensure compliance throughout the product lifecycle. The role will be responsible for preparing and managing regulatory submissions, registrations, post-market compliance activities, and regulatory documentation while partnering with cross-functional teams including R&D, Quality, Manufacturing, and Marketing.

The ideal candidate will have strong knowledge of medical device regulations, regulatory submission requirements, product registrations, and regulatory documentation management. This individual will serve as a regulatory liaison, support regulatory strategy activities, monitor changing regulatory requirements, and help ensure timely approvals and continued compliance of marketed products across global markets.

Key Responsibilities:

• Prepare, coordinate, and maintain 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.

Education:

Major/Field of Study or Equivalent

Technical Diploma (high school or equivalent)

Preferred 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.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, Life Insurance, short-term disability, additional voluntary benefits, an EAP Program, computer benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may eligible for paid leave including paid sick leave or any other paid leave required by federal, state or local law, as well as Holiday pay where applicable. Disclaimer: The benefit of offerings do not apply to client recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers