Government and Regulatory Affairs Specialist

$90,000 - $120,000/Yr

Bodorlaser Inc - Schaumburg, IL

Full-time - Senior

Schaumburg, IL

About the position

The Government and Regulatory Affairs Specialist at Bodorlaser Inc. plays a crucial role in managing regulatory compliance and government relations, particularly focusing on FDA regulations. This position is responsible for ensuring the company's adherence to regulatory requirements, facilitating communication with government agencies, and supporting strategic planning to navigate policy changes. The specialist will also represent the company at relevant events and conduct research on industry policies to maintain a competitive edge.

Responsibilities

• Serve as the primary liaison between the company and the FDA, ensuring compliance with all regulatory requirements.
• Monitor, interpret, and address FDA regulations that impact the company's products and operations.
• Work closely with external legal counsel to resolve FDA-related issues effectively.
• Proactively address regulatory hurdles to ensure timely product approvals and compliance.
• Track and analyze federal, state, and local government policies, legislation, and regulatory actions relevant to the company.
• Provide timely updates and recommendations to senior management and relevant teams.
• Develop and implement strategic action plans to address policy changes and regulatory challenges.
• Build and maintain relationships with key government agencies and officials, ensuring clear and open communication.
• Advocate for the company's interests to enhance its reputation and operational success.
• Represent the company at government-related events, including meetings, conferences, and seminars.
• Conduct research on industry-specific policies and trends, particularly those impacting laser technology and FDA regulations.
• Offer guidance to ensure regulatory compliance across operations.

Requirements

• Bachelor's degree in Public Administration, Political Science, Law, Business Administration, or a related field.
• Minimum 5 years of relevant experience in government affairs, regulatory compliance, or working with government agencies (preferably FDA-related).
• Comprehensive knowledge of FDA regulations and processes, with proven experience resolving FDA compliance issues.
• Strong analytical, communication, and relationship-building skills.
• Background or experience in government roles or regulatory affairs is preferred.
• Bilingual in Chinese Mandarin preferred.

Benefits

• Health savings account
• Visa sponsorship
• Disability insurance
• Health insurance
• Dental insurance
• Flexible spending account
• Paid time off
• Employee assistance program
• Vision insurance
• 401(k) matching
• Life insurance