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.