Job Description

• 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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