Principal Regulatory Affairs Specialist

Accountabilities: Lead regulatory strategies for new and modified medical device products, integrating regulatory requirements throughout development and lifecycle activities.

Prepare, submit, and maintain global product registrations, including FDA 510(k) submissions, EU Technical Documentation, International STEDs, and other applicable regulatory materials.

Partner with global and regional regulatory teams to coordinate market-access strategies and ensure submissions and registrations are executed effectively and on schedule.

Review product labeling and related materials to ensure alignment with applicable U.S., EU, and international medical device requirements.

Monitor emerging regulations and regulatory trends, assess their potential business impact, and provide actionable guidance to stakeholders.

Maintain regulatory intelligence, identify compliance risks, and develop mitigation strategies and practical solutions.

Provide regulatory guidance for customer inquiries, bids and tenders, customs requests, OEM and private-brand activities, and other commercial initiatives.

Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes that support consistent execution and continuous improvement.

Manage regulatory information, analytics, and reporting through regulatory information management systems, including trend analysis of submission activity.

Ensure product and regulatory requirements are implemented and maintained effectively to support ongoing compliance and international market access.

Independently manage multiple complex regulatory projects, providing strategic direction while proactively identifying risks, challenges, and business implications.

Contribute technical expertise, innovative solutions, and mentorship to less experienced colleagues and cross-functional partners.

Requirements

Bachelor’s degree in a scientific discipline or equivalent professional experience; an advanced understanding of medical device regulatory affairs is highly valued.

At least 5 years of regulatory affairs experience, preferably within the medical device industry.

Strong knowledge of U.S. FDA medical device regulations and experience preparing International STEDs and technical documentation.

Demonstrated experience developing regulatory strategies and managing submissions or registrations across multiple international markets.

Strong understanding of regulatory compliance, product lifecycle requirements, labeling, and regulatory intelligence.

Excellent organizational and project management skills, with the ability to manage multiple complex priorities while consistently meeting deadlines.

Strong analytical, problem-solving, written, and verbal communication skills.

Ability to work independently with general guidance while exercising sound judgment on complex regulatory matters.

Comfortable collaborating with global, regional, and cross-functional teams and communicating technical regulatory concepts to diverse stakeholders.

Ability to identify emerging regulatory risks, translate requirements into practical solutions, and balance compliance with business objectives.

Willingness and ability to travel up to 10% of the time, including travel to relevant business locations or meetings as required.

Benefits

Anticipated salary range of $80,900–$127,050 , with actual compensation determined by factors such as location, education, experience, skills, and internal pay equity.

Remote work opportunity within the United States, with an expectation of up to 10% travel.

Medical, dental, and vision coverage.

Health Savings Account (HSA) and Flexible Spending Account (FSA) options.

401(k) savings plan.

Paid time off.

Paid parental leave.

Short- and long-term disability coverage.

Flexible access to wages through myFlexPay.

Work-life resources and employee support programs.

Healthy lifestyle and well-being programs.

Inclusive workplace committed to diversity of thought, experience, and background.

Opportunity to work on complex, high-impact regulatory initiatives supporting global medical device market access.

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