Government and Regulatory Affairs Specialist

Location: Schaumburg, IL office or Houston, TX

Type: Full Time Perm – Direct Hire

Bilingual: Bilingual in Mandarin highly preferred

Prefer: Ideally, the candidate should have a background in manufacturing companies that import products from overseas, such as industries regulated by the FDA and CBP (e.g., laser products, medical devices).

Role Description:

We are seeking a skilled Government and Regulatory Affairs Specialist to address regulatory and compliance issues, with a current priority on resolving challenges related to FDA regulations and processes. This role will focus on facilitating smooth interactions with government agencies, supporting regulatory compliance, and safeguarding the company’s interests and reputation. This role will be reporting to our CEO and can be based either in our Schaumburg, IL office or Houston, TX office.

Key Responsibilities:

1. FDA Regulatory Compliance (Priority Focus):

• 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.

2. Policy Monitoring and Analysis:

• 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.

3. Strategic Planning and Advisory:

• Develop and implement strategic action plans to address policy changes and regulatory challenges.
• Offer expert policy interpretations and decision-making support to senior management.

4. Government Relations and Advocacy:

• 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.

5. Event Participation and Representation:

• Represent the company at government-related events, including meetings, conferences, and seminars.
• Prepare necessary documentation and reports for government interactions.

6. Industry Policy Research:

• Conduct research on industry-specific policies and trends, particularly those impacting laser technology and FDA regulations.
• Provide insights to maintain a competitive edge in the industry.

7. Operational Support and Risk Management:

• Offer guidance to ensure regulatory compliance across operations.
• Collaborate with internal teams and external legal counsel to mitigate risks and resolve compliance issues.

Qualifications:

• 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.