Compliance Specialist

About Endoscopex: Endoscopex is a leading provider of medical equipment specializing in endoscopy products. Committed to excellence and innovation, we strive to deliver high-quality solutions that enhance patient care and support healthcare professionals worldwide.

Position Overview: Endoscopex is seeking a highly detail-oriented and knowledgeable Compliance Specialist to join our team. The Compliance Specialist will be responsible for ensuring that the company operates in compliance with all applicable laws, regulations, and industry standards. The ideal candidate will have a strong understanding of regulatory requirements, excellent communication skills, and the ability to collaborate effectively with internal and external stakeholders.

Responsibilities:

1. Develop, implement, and maintain compliance programs, policies, and procedures to ensure adherence to applicable laws, regulations, and industry standards.
2. Monitor changes in regulatory requirements and communicate updates to relevant stakeholders, providing guidance and recommendations as needed.
3. Conduct regular compliance audits and assessments to evaluate the effectiveness of existing compliance programs and identify areas for improvement.
4. Investigate compliance issues, incidents, and complaints, documenting findings and recommending corrective actions to prevent recurrence.
5. Collaborate with cross-functional teams, including legal, regulatory affairs, quality assurance, and operations, to address compliance-related issues and implement solutions.
6. Provide training and education to employees on compliance policies, procedures, and regulations, ensuring awareness and understanding of their responsibilities.
7. Serve as a subject matter expert on compliance matters, providing guidance and support to internal stakeholders and external partners as needed.
8. Maintain accurate records and documentation related to compliance activities, audits, and investigations.
9. Monitor and track compliance metrics and key performance indicators (KPIs), preparing reports and presentations for management review.
10. Stay abreast of industry trends, best practices, and emerging regulatory issues to inform compliance strategies and initiatives.

Qualifications:

1. Bachelor’s degree in business administration, healthcare administration, legal studies, or a related field required; advanced degree or professional certifications (e.g., Certified Compliance and Ethics Professional) preferred.
2. 3+ years of experience in compliance roles, preferably in the healthcare or medical device industry.
3. Strong understanding of regulatory requirements related to healthcare compliance, including but not limited to FDA regulations, HIPAA, and Sunshine Act reporting.
4. Excellent analytical and problem-solving skills, with the ability to interpret and apply complex regulations and policies.
5. Excellent communication and interpersonal skills, with the ability to effectively communicate with stakeholders at all levels of the organization.
6. Ability to collaborate and build relationships with cross-functional teams to achieve compliance objectives.
7. Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines simultaneously.
8. Proficiency in Microsoft Office Suite and other software applications used for compliance management and reporting.
9. Commitment to integrity, professionalism, and ethical conduct in all aspects of compliance activities.
10. Ability to work independently with minimal supervision and as part of a team.