Regulatory Affairs Specialist

Overview

Prepare and submit FDA 510(k) and Health Canada device submissions, ensure compliance.

Key Responsibilities

• regulatory review
• submission prep
• compliance support
• document verification
• protocol approval
• pre-market

Tasks

-Review and approve protocols and reports to support regulatory submissions. -Write and lead the completion of high-quality pre-market submissions. -Support post-market regulatory compliance activities. -Prepare and submit appropriate documentation for pre-market submissions, such as FDA 510(k) submissions and Health Canada Medical Device License Applications. -Review and verify documents and technical information for regulatory submissions from various functional areas, ensuring accuracy and completeness.

Requirements

• iso
• health canada
• mdd
• mdsap
• fda cfr
• 3 years

What You Bring

-Experience with ISO standards and filing regulatory submissions with Health Canada. -Familiarity with Canadian Medical Device Regulations, MDD, and MDSAP. -Experience with regulatory compliance and labeling. -In-depth knowledge and experience of FDA 21 CFR Part 820 and 510(k) submission requirements. -Ability to handle regulatory documents effectively. -Minimum of three (3) years of medical device regulatory and/or quality experience.

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About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms