Principal Regulatory Affairs Specialist

About This Opportunity

We are representing a confidential medical device organization in their search for a Principal Regulatory Affairs Specialist. This remote role will support regulatory affairs activities for the medical solutions division, focusing on new product development, change management, and global regulatory submissions. The ideal candidate will be located near or willing to travel to locations in Illinois or Massachusetts.

Responsibilities

• Lead new and modified product development projects, establishing and integrating regulatory strategy throughout project lifecycles
• Prepare, submit, and maintain global product registrations with emphasis on 510(k) submissions, EU Technical Documents, and International STEDs
• Collaborate with international regulatory departments to assess requirements, develop strategies, and ensure timely execution of registrations
• Review design control documents including design inputs and outputs for regulatory compliance
• Review product labeling to ensure compliance with global labeling regulations
• Interpret proposed medical device regulations and advise on business impact
• Maintain regulatory intelligence through continuous monitoring of the regulatory landscape; identify risks and develop mitigation strategies
• Provide regulatory support for customer queries, bid and tender submissions, and customs inquiries
• Develop and implement regulatory procedures and SOPs

What We're Looking For

• Bachelor's degree in a scientific discipline or equivalent work experience preferred
• 5+ years of regulatory affairs experience preferred
• Experience in the medical device industry highly valued
• Proficiency in US and European medical device regulations strongly preferred
• Strong organizational and problem-solving capabilities
• Excellent oral and written communication skills
• Proven ability to manage multiple projects while meeting deadlines
• Ability to travel up to 10% of the time
• Demonstrated ability to apply comprehensive knowledge to varied tasks and complex projects
• Experience developing innovative solutions consistent with organizational objectives
• Capability to work independently with general guidance on new projects
• Experience mentoring less experienced colleagues is a plus

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Please do not contact the client organization directly, as all communications should flow through our recruiting team to ensure a smooth process.

Pay

This position offers competitive compensation. Our client has indicated an anticipated salary range of $80,900 - $127,050 for this role. Additionally, our client offers comprehensive benefits including medical, dental and vision coverage, paid time off, 401k savings plan, HSA, flexible spending accounts, short- and long-term disability coverage, paid parental leave, and work-life resources.

Equal Opportunity

Get A Job.ai is committed to inclusive hiring practices. We encourage applications from all qualified candidates regardless of race, religion, color, national origin, age, disability status, sex, sexual orientation, gender identity, pregnancy, veteran status, or any other protected characteristic.