Regulatory Manager

Overview

Strategic regulatory affairs manager leading global device submissions and compliance.

Key Responsibilities

• audit support
• regulatory submissions
• submission deficiencies
• regulatory strategy
• project lifecycle
• team coordination

Tasks

-Support Audits and inspections -Manage full project/ product lifecycle as main representative on cross- functional product development teams (R&D, Engineering, Quality, Manufacturing, Clinical and Marketing) to ensure regulatory requirements are integrated into product development and documentation -Communicate impact to internal stakeholders -Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified Bodies. -Address submission deficiencies -Development and execution of regulatory strategies for New Product Development and sustaining engineering projects

Requirements

• e-star
• fda
• eu
• mdr
• product development

What You Bring

-Experience supporting both new product development and sustaining activities. -Word copy of resume -Proven track record of successful submissions to, and experience interacting with, US FDA and EU Notified Bodies. -4-5 brief bullet points highlighting technical qualifications Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. This role is key in driving strategy for both new product development and engineering lifecycle management. -Strong understanding of global medical device regulations (e.g., FDA CFR, EU MDR). -2-3 professional references -e‑STAR experience = ability to effectively prepare and submit FDA-compliant device filings

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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.

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