Compliance Manager

This is a fully remote position, open to applicants in Florida, +1 more state.

📋 Description

• Lead and manage compliance initiatives while ensuring adherence to regulatory standards and both local and federal laws.

• Plan, execute, and implement compliance initiatives across various global jurisdictions.

• Communicate potential risks and strategies for mitigation to stakeholders.

• Develop project plans, timelines, and strategies for resource allocation.

• Serve as a liaison among Quality, Regulatory, Operations, IT, and Product Management teams.

• Conduct project meetings, provide updates on status, and communicate risks to stakeholders and senior leadership.

• Monitor project milestones and deliverables.

• Incorporate compliance requirements into business processes.

• Create and deliver strategic compliance training programs.

• Contribute to the corporate compliance strategy and global quality initiatives.

• Design, implement, and sustain the vendor qualification program.

• Lead vendor qualification and approval processes, including audits, technical assessments, and quality risk evaluations.

• Develop and maintain vendor risk classifications.

• Coordinate vendor onboarding and establish contract quality agreements in collaboration with QA, Supply Chain, Procurement, and Legal teams.

• Set up and track vendor performance metrics.

• Stay informed about global regulatory requirements and industry best practices.

• Develop and implement regulatory strategies for market entry in Europe.

• Identify country-specific requirements and perform regulatory gap assessments.

• Compile documentation specific to Europe.

• Integrate local requirements into global processes.

• Conduct compliance risk assessments prior to product or process launches.

• Maintain licenses and registrations, ensuring that SOPs comply with applicable regulations.

• Mentor and develop compliance staff.

• Lead and empower team members while managing targets and KPIs.

⛳️ Requirements

• Bachelor’s degree in a science-related field.

• A minimum of five (5) to seven (7) years of experience in a managerial role within Quality, Compliance, or Regulatory Affairs, totaling at least 10 years of experience.

• Familiarity with FDA, Health Canada, TGA, and EMA regulations.

• Proficiency in project management.

• Proficient in Microsoft Office Suite (Word, Outlook, and Excel) is required.

• Knowledge of Creatio and MasterControl is an advantage.

• Strong writing abilities.

• Dependable, accountable, and detail-oriented.

• Highly organized with excellent judgment and decision-making skills.

🏝️ Benefits

• Paid time off (PTO), vacation policy, and paid statutory holidays.

• Group benefit plan and health savings account.

• Opportunities for learning and growth within Medisca.

• 401(k) retirement plan.

• Employee Referral Program.

• Company events held throughout the year.