Healthcare Compliance Specialist (Hourly, 30-hour full-time, $25-28 per hour)

Review analytical frameworks to monitor regulatory compliance needs across all product lines to help with compliance, including but not limited to data entry, maintenance of documents, audit reports, and incident reporting alerts
Communicates compliance issues and findings identified through audits and reviews. Prepares written audit reports and communicates the results to management. Initiates corrective action plans or continuous improvement plans identified through audits
Develop training systems and conduct ongoing training and educational support to internal staff.
Communicate applicable risks and costs regarding any potential new business initiatives to all relevant stakeholders.
Advocate compliance mission and manage relationships across the company to ensure that the team is well positioned from concept to execution.
Conduct analyses of the business impacts posed by regulatory requirements and proposed changes to Neofect’s leadership.
Play an active role in conducting compliance risk assessments as well as developing and supporting implementation of mitigation plans regarding business roadmap.
Assist in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports.
Responsible for FDA submissions, maintaining regulatory reporting and complaint systems, and coordination for communication with FDA.
Ensures Regulatory and legal compliance of all Neofect external communications including but not limited to, sales training, marketing and social media.

Required/Preferred knowledge base

Bachelor's degree required
Remain up-to-date on regulatory changes and landscape, best practices and new developments in the medical device and software industry.
Maintain confidentiality and comply with Health Insurance Portability and Accountability Act (HIPAA).

Experience

1-3 years of related, applicable experience in compliance related to compliance in medical device markets.
Independent and deadline driven.
Ability to execute independently and work with team members of all levels.

Benefits

401(k)
Insurance: Medical, Dental, Vision
Paid time off

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