Clinical Compliance Specialist
16 hours ago
About TFS HealthScience
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
The Project Manager – MDR Compliance will lead and coordinate efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks. This includes developing project plans, setting goals, managing resources, mitigating risks, and ensuring timely delivery within scope.
This role requires on-site presence as well as remote flexibility and is part of our SRS/FSP team dedicated to one sponsor.
Key Responsibilities:
- Develop and implement strategies to align with regulatory requirements.
- Coordinate with cross-functional teams, including legal, quality assurance, and operations.
- Ensure project milestones are met while maintaining high-quality standards.
- Manage risk assessment and mitigation strategies.
- Communicate project updates to stakeholders and regulatory bodies.
Qualifications:
- Minimum three years of experience in project management.
- Strong knowledge of MDR and regulatory compliance frameworks.
- Experience in implementing regulatory policies and management systems.
- Proven ability to lead teams and engage stakeholders.
- Strong communication and problem-solving skills.
- Fluency in both Swedish and English.
We Offer
A competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment where collaboration, innovation, and making a difference in the lives of patients are valued.
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