Regulatory Affairs Specialist

Actalent is seeking a Regulatory Affairs Specialist to execute regulatory strategies that support the registration and life-cycle management of innovative medical devices. This role combines compliance and submission responsibilities, supporting global programs and ensuring clear communication with cross-functional partners.

About the role

As a key member of the Regulatory Affairs team, you will support global regulatory programs, ensuring compliance with applicable frameworks for medical devices. The position requires an intermediate understanding of medical devices and their regulatory requirements, with a strong sense of urgency and ownership for worldwide projects. This role is based in a modern facility in Huntersville, NC, emphasizing quality and collaboration with manufacturing and on-site teams. The work supports products serving critical applications, including military personnel and first responders.

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.
• Assist with international product registrations and regulatory submissions across multiple regions and markets.
• Support 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.
• Support compliance-driven projects and regulatory remediation efforts, contributing to corrective and preventive actions as needed.
• 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.
• Work independently on assigned regulatory tasks while collaborating effectively with cross-functional teams to meet project timelines.

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.
• Proven experience reviewing and assessing change controls from a regulatory perspective.
• Ability to evaluate the regulatory impact of product, process, and documentation changes on existing registrations and compliance status.
• Strong knowledge of FDA 21 CFR Part 820 and its application to medical device quality systems.
• Strong knowledge of EU MDR requirements and their impact on technical documentation and post-market activities.
• Strong knowledge of MDSAP requirements and related compliance expectations.
• Familiarity with relevant ISO standards applicable to medical devices and quality management systems.
• 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.

Additional 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.

Pay

The pay range for this position is $80,000.00 - $90,000.00 per year.

Schedule

This is a permanent, fully onsite position based in Huntersville, NC.