Provide regulatory guidance and support to cross-functional teams for both new product development and sustaining projects.
Complete regulatory deliverables for assigned projects, including strategy development, impact assessments, and submission preparation through to clearance or approval.
Prepare global submissions including but not limited to U.S. FDA 510(k) Premarket Notifications, PMA submissions, EU MDR Technical Documentation, and other international product registrations.
Collaborate with cross-functional teams to collect and review technical documentation, ensuring accuracy, regulatory compliance, and timely submissions.
Communicate and negotiate with global regulatory bodies during submission reviews, audits, and post-market activities.
Identify risks and develop contingency plans for assigned regulatory projects.
Interpret and communicate regulatory requirements and guidance to internal teams and stakeholders.
Maintain regulatory databases, trackers, and documentation in accordance with internal procedures and applicable regulations.
Support compliance-related activities such as site registrations, audits, and post-market surveillance (e.g., HHEs, MDRs, FAs, CAPAs).
Apply quality system knowledge to all job functions.
Perform additional tasks as assigned by the Regulatory Manager.
Comply with Enovis's Code of Conduct, company policies, procedures, and standards.

Bachelor’s degree in a scientific discipline (e.g., biology, microbiology, chemistry, engineering, or medical technology).
Minimum 2 years of regulatory affairs experience in the medical device industry.
Proven experience preparing U.S. FDA 510(k) submissions.
Understanding of design and change control processes, regulatory assessments, and quality system requirements under ISO 13485 and FDA QSR.
Experience working cross-functionally and with regulatory agencies.
Ability to travel 20%.

Regulatory Affairs Specialist

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