Compliance Manager

🕒 October 5

🐊 Florida, Texas – Remote

🐊 Florida – Remote 🤠 Texas – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 11%

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Medisca

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1989

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

Healthcare • Manufacturing • Healthcare Insurance

Medisca is a company dedicated to empowering personalized wellness across various regions including North America, Asia Pacific, Europe, South America, the Middle East, and Africa. Founded in 1989, Medisca focuses on providing customized healthcare solutions to enhance individual well-being.

📋 Description

• Lead and oversee compliance initiatives while ensuring adherence to regulatory requirements and local and federal laws • Plan, execute, and deliver compliance initiatives across multiple global jurisdictions • Communicate potential risks and mitigation strategies to stakeholders • Develop project plans, timelines, and resource allocation strategies • Liaise between Quality, Regulatory, Operations, IT, and Product Management • Lead project meetings, provide status updates, and communicate risks to stakeholders and senior leadership • Track project milestones and deliverables • Integrate compliance requirements into business processes • Develop and deliver strategic compliance training programs • Contribute to corporate compliance strategy and global quality initiatives • Design, implement, and maintain the vendor qualification program • Lead vendor qualification and approval, including audits, technical assessments, and quality risk evaluations • Develop and maintain vendor risk classifications • Coordinate vendor onboarding and contract quality agreements with QA, Supply Chain, Procurement, and Legal • Establish and track vendor performance metrics • Maintain knowledge of global regulatory requirements and industry best practices • Develop and implement regulatory strategy for go-to-market in Europe • Identify country-specific requirements and conduct regulatory gap assessments • Compile Europe-specific documentation • Integrate local requirements into global processes • Conduct compliance risk assessments before product or process launches • Maintain licenses and registrations and ensure SOPs follow applicable regulations • Mentor and develop compliance staff • Lead and empower team members and manage targets and KPIs

🎯 Requirements

• Bachelor’s degree in a Science related field • Minimum of five (5) to seven (7) years experience in a managerial role in Quality, Compliance or Regulatory Affairs, with 10 years total experience • Knowledge of FDA, Health Canada, TGA and EMA regulations • Knowledge in project management • Knowledge of Microsoft Office suite (Word, Outlook and Excel) required • Knowledge of Creatio and MasterControl is an asset • Strong writing skills • Reliable, accountable, detail-oriented • Organized, very good judgment and decision making skills

🏖️ Benefits

• PTO, vacation policy and paid statutory holidays • Group Benefit plan and health savings account • Opportunities to learn and grow within Medisca • 401k plan retirement • Employee Referral Program • Company events throughout the year

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