US Regulatory Affairs Specialist

Overview

Employer Industry: Medical Device Manufacturing

• Salary up to $84,992
• Eligible for bonus/incentive not reflected in the posted range
• Comprehensive benefits package including Medical, Dental, and Vision Coverage, 401K Plan with Company Match, and Paid Parental Leave
• Opportunities for professional development and educational benefits
• Supportive work environment with a focus on compliance and regulatory excellence
• Minimal travel requirements (typically less than 10%)

• Research and analyze laws and regulations to ensure ongoing compliance with Federal, State, and local requirements
• Initiate and maintain medical device product registrations globally, focusing on international markets
• Provide regulatory input to product lifecycle planning and assist in SOP development
• Compile, prepare, review, and submit regulatory submissions to authorities
• Monitor applications under regulatory review and provide support during inspections

• 2-4 years of experience in medical device manufacturing or regulatory submissions
• Experience with FDA pre-market submissions preferred
• Good understanding of industry practices and regulatory requirements
• Strong verbal and written communication skills
• Basic planning, organizational skills, and decision-making abilities

• Experience with ISO 13485 and EU MDR preferred
• Good presentation and public speaking skills
• Basic conflict resolution skills
• Developing professional credibility
• Experience in product recalls and recall communications

#Medical Devices #Regulatory Compliance #Career Opportunity #Competitive Pay #Professional Development

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