
Senior Regulatory Affairs and Compliance Officer
19 hours ago
Optimiza is looking for a proactive and experienced Senior Regulatory Affairs and Compliance Officer to ensure that our products and operations comply with applicable regulations and industry standards. In this pivotal role, you will work closely with various teams to provide regulatory guidance and develop strategies that promote compliance while facilitating business initiatives.
Key Responsibilities:
- Oversee and manage the regulatory compliance program, ensuring adherence to local, state, and federal regulations that impact the organization's operations.
- Review, analyze, and interpret regulatory requirements and communicate their implications to stakeholders across the organization.
- Develop and implement robust compliance strategies and training programs to promote a culture of compliance within the organization.
- Collaborate with cross-functional teams, including product development, marketing, and legal, to ensure that all product submissions meet regulatory requirements.
- Prepare and submit regulatory documentation, applications, and reports to regulatory authorities in a timely manner.
- Lead compliance audits and assessments to identify areas of risk and implement corrective actions as necessary.
- Monitor changes in regulations and industry guidelines, providing updates and recommendations to management on necessary adjustments to policies and practices.
- Serve as the primary point of contact for regulatory agencies during audits and inspections.
Requirements
- Master's degree in Regulatory Affairs, Public Health, Law, or a related field; Bachelor's degree with significant experience may be considered.
- 7+ years of experience in regulatory affairs, compliance, or related fields, preferably in a senior role.
- In-depth knowledge of applicable regulatory requirements and industry standards.
- Proven experience in managing compliance programs and interactions with regulatory agencies.
- Exceptional analytical skills and attention to detail with a focus on problem-solving and risk assessment.
- Strong communication and interpersonal skills to effectively engage with various stakeholders.
- Demonstrated ability to manage multiple projects and deadlines while maintaining high-quality standards.
- Relevant certifications in regulatory affairs (e.g., RAC) are advantageous.
- Strong understanding of regulatory frameworks and the ability to interpret complex regulations.
Benefits
- Class A Health Insurance
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