Compliance Manager

Medisca; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

PTO and holidays

Health benefits

401(k) plan

Employee referral program

Company events

Career growth opportunities

Job summary

Medisca seeks a Compliance Manager to lead global regulatory compliance initiatives, including vendor qualification programs and regulatory strategy for go-to-market in Europe. You will partner with Quality, Regulatory, Operations, IT and Product Management to ensure adherence to FDA, Health Canada, EMA, and TGA standards.

The role requires strong project management, cross-functional collaboration, and the ability to mentor staff while driving KPIs.

Qualifications

• Bachelor's degree in a Science related field required.
• 5–7 years in managerial role in Quality, Compliance or Regulatory Affairs with total 10 years experience.
• Knowledge of FDA, Health Canada, TGA and EMA regulations.
• Experience with vendor management and global regulatory programs.
• Proficient with MS Office; prior experience with Creatio or MasterControl is an asset.

Responsibilities

• Plan, lead and manage compliance initiatives across global jurisdictions.
• Communicate risks and mitigation strategies to stakeholders.
• Develop detailed project plans, timelines and resources to meet compliance goals.
• Collaborate with QA, Regulatory, Operations, IT and Product Management to ensure cross-functional alignment.
• Lead meetings, provide status updates and monitor milestones.
• Oversee vendor qualification and onboarding processes with audits and assessments.

Skills

Regulatory knowledge

Project management

Microsoft Office

Vendor management

Education

Bachelor's degree in a Science related field

Tools

Creatio

MasterControl

GxP systems

Job description

Job Category:

Regulatory Affairs / Compliance

Medisca is a global companyleveragingstrong partnerships to serve healthcare professionals across diverse wellness disciplines. Offering extensive and essential solutions - including pharmaceutical ingredients and service, mixing technology manufacturing, analytical testing, and education –Medisca is bridging the gaps in healthcarewith an unwavering commitment to precision, innovation, and societal impact.

TheCompliance Manageris responsible forleading and overseeing compliance initiativeswhileensuringadherenceof all regulatory requirementsin accordance withlocal and federal laws.This role will focus on planning, executing, and delivering initiatives that ensure regulatory compliance with applicable global standards (FDA, Health Canada, TGA and EMA).This role will also focus on leading thevendorprograms. The ideal candidate will bring strong regulatory knowledge, risk assessment capabilities, and cross-functional collaboration skills to ensure all vendors meet quality,complianceand performance standards.

The opportunity:

Compliance

• Plan,manageand executecompliancedriveninitiatives across multiple globaljurisdictions
• Communicate potential risks and mitigation strategies to stakeholders
• Develop detailed project plans, timelines and resource allocation strategies while ensuring complianceobjectivesare met
• Act as a liaison between Quality, Regulatory,Operations, IT and Product Management to ensure seamless execution of cross functional initiatives
• Lead project meetings, provide status updates, and communicate risks and mitigation plans to stakeholders and senior leadership
• Track project milestones and deliverables
• Collaborate with cross-functional teams to integrate compliance requirements into business processes
• Develop and deliver strategic compliance training programs to ensure cross-functional awareness and accountability
• Serve as a key member of the management team, contributing to corporate compliance strategy and global quality initiatives.

Oversight ofVendor Qualification Program

• Design, implement andmaintainthe vendor qualification programin accordance withglobal compliance requirements (FDA, Health Canada,EMAand TGA)
• Lead thequalification and approval process for new vendors, including audits, technical assessments, and quality risk evaluations
• Develop andmaintainvendor risk classifications based on criticality and performance
• Work with cross-functional teams (QA, Supply Chain, Procurement, Legal) to ensure proper vendor onboarding and contract quality agreements
• Establish and track vendor performance metrics
• Maintain up-to-date knowledge of relevant global regulatory requirements and industry best practices related to vendor management

Develop and implement regulatory strategy for go to market in Europe

• Identifycountry specific requirements
• Conduct regulatory gap assessments of current procedures, for implementation in European market
• Compile European specific documentation
• Integrate local requirements within Global processes, where applicable
• Conduct compliance risk assessments prior to product or process launches
• Maintain licenses and registrations, ensuring SOPs follow applicable regulations
• Mentor and develop staff within compliance functions
• Lead and empowermembers oftheteam;guide them to perform at their best. Set and manage clear targets and KPIs andmonitorprogress.
• Foster ahigh drivenculture within your team by empowering them to bring their best selves to work.

Qualifications:

• 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 EMAregulations.
• Knowledge in project management.
• Knowledge of Microsoft Office suite (Word, Outlook and Excel) required.
• Knowledge of Creatio and MasterControl is an asset.
• Reliable, accountable, detail-oriented.
• Organized, very good judgment and decision making skills.

What’sin it for you…

We invest time and resources into making sure Medisca is as good as the people we hire.

• Balance Your Life – PTO, vacation policy and paid statutory holidays
• Invest in your health – Group Benefit plan and health savings account
• Your Future is Bright – Opportunities to learn and grow within Medisca
• Save for your Future – 401k plan retirement
• Help us grow – Employee Referral Program
• We like to have fun – company events throughout the year

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.