Regulatory Affairs Specialist

Enovis•Atlanta, GA

2d•Hybrid

About The Position

Enovis Corporation is seeking a skilled and experienced Regulatory Affairs Specialist to join their team. This role will support a wide range of regulatory activities to ensure compliance with global submission requirements, departmental processes, and quality system standards. The specialist will develop regulatory strategies, complete impact assessments, and prepare submissions including U.S. FDA 510(k)s, EU MDR Technical Documentation, and other OUS registrations. The RA Specialist will support the Foot & Ankle Business Unit (F&A BU), contribute to new product development and sustaining projects, and engage with global regulatory authorities including the FDA and EU Notified Body.

Requirements

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%

Nice To Haves

Experience with international registrations and submissions including EU MDR.
Knowledge of medical device labeling and associated regulations.
High attention to detail with a focus on accuracy and completeness.
Strong written and verbal communication skills.
Excellent organizational, planning, and time management abilities.
Analytical and problem-solving mindset.

Responsibilities

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.