US Regulatory Affairs Specialist

About the Opportunity

This position as a US Regulatory Affairs Specialist is responsible for acquiring and maintaining product registrations for domestic and international markets. It provides direction regarding applicable U.S. and international regulations and ensures ongoing compliance with Federal, State, and local legislation.

Responsibilities

• Research and analyze applicable laws and regulations.
• Develop and implement policies and procedures for regulatory compliance.
• Initiate and maintain global medical device product registrations, focusing on international markets.
• Support development of regulatory strategies and processes.
• Collaborate with subsidiary offices and distributors on product legal and regulatory compliance.
• Ensure only legally registered products are sold internationally per U.S. export regulations.
• Assist in SOP development and review.
• Provide regulatory input for product lifecycle planning.
• Compare regulatory outcomes with initial product concepts and recommend future actions.
• Determine and communicate submission and approval requirements.
• Participate in risk benefit analysis for regulatory compliance.
• Assess quality, preclinical, and clinical documentation for submission filing.
• Compile, prepare, review, and submit regulatory submissions to authorities.
• Monitor changes in regulations impacting submission strategies.
• Track applications under regulatory review.
• Support inspections and formulate responses and corrective actions.
• Assist with compliance for post marketing approval requirements.
• Review regulatory aspects of contracts.
• Assist with label and Instructions for Use (IFU) development and compliance review.
• Manage multiple establishment and product registration activities.
• Submit and review change controls to determine submission requirements.
• Provide regulatory input for product recalls and communications.
• Perform other duties as assigned.

Requirements

To succeed as a US Regulatory Affairs Specialist, candidates should possess:

• 2 to 4 years preferred experience in medical device regulatory submissions (U.S. FDA regulated and registered).
• Experience with FDA pre-market submissions preferred.
• Experience with ISO 13485 and EU MDR preferred.
• Good understanding of industry practices.
• Proficient with regulatory tools, systems, and procedures.
• Basic planning and organizational skills.
• Strong decision making, analysis, and problem-solving skills.
• Ability to multi-task.
• Effective verbal and written communication skills.
• Presentation and public speaking skills.
• Interpersonal skills and basic conflict resolution abilities.
• Developing professional credibility.
• Typically a Bachelor's Degree or global equivalent in a related discipline.
• Travel less than 10%, office environment, no special physical demands.

Compensation, Benefits & Perks

The compensation for this role ranges from $61,812 to $84,992, with eligibility for a bonus. Comprehensive benefits include Medical, Dental, and Vision Coverage, a 401K Plan with Company Match, Paid Time Off, Paid Parental Leave, and various other programs to support work-life balance and professional development.

Key skills/competency

• Regulatory Submissions
• Medical Device Regulations
• FDA Compliance
• ISO 13485
• EU MDR
• Product Registration
• Regulatory Strategy
• Compliance Policies
• Risk Analysis
• Quality Documentation