Regulatory Affairs Manager - cGxPServe : Job Details

Regulatory Affairs Manager

cGxPServe

Job Location : Richmond,IL, USA

Posted on : 2025-08-06T06:22:27Z

Job Description :

Responsibilities

Prepare and submit new global market device applications and amendments.
Prepare and oversee the review of Traditional 510(k) Premarket Notifications.
Develop and implement regulatory filing timelines for new and existing products in key markets such as US, EU, and Asia markets.
Interact with regulatory agency reviewers as well as distribution partners to facilitate product registrations and third-party license holders.
Write and maintain EU MDR technical documentation, including change notifications, and lead EU related regulatory activities.
Lead global regulatory assessments for product and manufacturing process changes via the document control process. Prepare and submit global regulatory product updates, as required.
Serve as the voice of regulatory on cross-functional teams, including working with product development and manufacturing engineers to ensure regulatory requirements are incorporated throughout the product lifecycle.
Interpret applicable standards, regulations, and directives to ensure global regulatory compliance.
Review product labeling for global compliance.
Develop regulatory processes that apply to US and international locations.

Requirements

Bachelor's degree in science, Engineering, Regulatory Affairs, or other technically related fields.
8+ years of experience with Class II and/or III medical devices, including EU MDR/MDD experience. Devices containing software and hardware systems, preferred.
Extensive experience writing/authoring US, EU, and other key market submissions.
Experience with international medical device regulations, standards, and guidance documents including MDSAP, EU MDR, and ISO 13485.
Excellent regulatory-focused writing skills, communication skills, interpersonal and collaboration skills.
Attention to detail, and ability to manage and prioritize multiple projects simultaneously.
Effective time management and outstanding organizational skills.
Demonstrated capabilities as a people manager, including proven experience delegating and mentoring.

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