Regulatory Affairs Specialist

Responsibilities

• Review and approve change control requests from a Regulatory Affairs perspective, ensuring proposed changes align with applicable regulatory requirements.
• Perform detailed regulatory assessments to determine the impact of proposed product, process, and documentation changes on global registrations and compliance.
• Conduct comprehensive labeling reviews to verify accuracy and ensure compliance with FDA, EU MDR, and other international regulatory requirements.
• Support EU MDR regulatory activities, including the preparation, maintenance, and ongoing updates of Technical Documentation.
• Aid in international product registrations and regulatory submissions across multiple regions and markets.
• Assist with new product introduction (NPI) projects by providing regulatory guidance and ensuring regulatory deliverables are met on time.
• Partner closely with Quality, R&D, Manufacturing, and other internal teams to maintain regulatory compliance throughout the product lifecycle.
• Serve as the primary Regulatory reviewer for change controls within the first six months, owning the assessment and approval process.
• Own and support labeling reviews during the initial six months, establishing robust review practices and documentation.
• Contribute to cross-functional regulatory projects, including NPI initiatives, compliance programs, and other regulatory project work aligned with experience level.
• Communicate regulatory requirements and expectations clearly to business partners worldwide, fostering alignment and timely decision-making.

Requirements

• At least 3 years of progressive Regulatory Affairs experience in medical devices and/or pharmaceuticals, with direct exposure to medical device regulatory activities.
• Demonstrated experience supporting regulatory activities for medical devices, including submissions and registrations.
• Strong understanding of FDA regulatory requirements for medical devices and relevant international regulatory frameworks.
• Hands-on experience with EU MDR Technical Documentation and supporting EU MDR submissions and compliance activities.
• Bachelor’s degree required.
• Prioritization of hands-on experience with change controls from a regulatory perspective.
• Evaluation of the regulatory impact of product, process, and documentation changes on existing registrations and compliance status.
• Knowledge of FDA 21 CFR Part 820 and its application to medical device quality systems.
• Knowledge of EU MDR requirements and their impact on technical documentation and post-market activities.
• Knowledge of MDSAP requirements and related compliance expectations.
• Detail-oriented approach with the ability to learn quickly and manage multiple regulatory tasks simultaneously.
• Ability to work independently while collaborating effectively with cross-functional teams in a fast-paced environment.
• Strong written and verbal communication skills for preparing regulatory documentation and interacting with global stakeholders.

Qualifications

• Exposure to regulatory activities in the European Union (EU), including support for regional submissions and compliance.
• Exposure to regulatory activities in Latin America (LATAM), including understanding of regional regulatory expectations.
• Exposure to regulatory activities in Gulf Cooperation Council (GCC) countries and related regulatory processes.
• Involvement in new product introduction (NPI) projects, providing regulatory input from concept through launch.
• Experience working on cross-functional project teams, contributing regulatory expertise to broader business initiatives.
• Experience supporting multiple international markets simultaneously, managing competing priorities and timelines.
• Demonstrated ability to thrive in a collaborative environment with a strong sense of urgency.
• Motivation to work on products that support critical applications, including those designed to aid military personnel and first responders.

Skills

• Intermediate understanding of medical devices, their use, and the regulatory frameworks that govern them.
• Strong sense of urgency and ownership to regulatory projects worldwide.

Benefits

The pay range for this position is $80000.00 - $90000.00/yr.

Schedule

This is a Permanent position based out of Raleigh, NC.

Work Environment

The role is based in a clean, modern, and brand-new facility that emphasizes quality and operational excellence. Much of the work supports assembly-focused operations, requiring close collaboration with manufacturing and other on-site teams. Team members work with a strong sense of urgency, driven by the impact these products have on end users, including military personnel and first responders. The environment is highly collaborative, offering significant opportunities for professional growth, cross-functional exposure, and involvement in meaningful, mission-driven projects.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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