What are the responsibilities and job description for the Regulatory Affairs Specialist position at Comrise?
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 :
3. Strategic Planning and Advisory :
4. Government Relations and Advocacy :
5. Event Participation and Representation :
6. Industry Policy Research :
7. Operational Support and Risk Management :
Qualifications :
