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Medical Compliance Manager - Waukesha, United States - Woodway USA
Description
Job Description
Job DescriptionOverview:
We are seeking a highly skilled and detail-oriented Medical Compliance Manager to oversee regulatory compliance within our medical device manufacturing company.
The ideal candidate will possess comprehensive knowledge of UL, FDA, CSA, NSF, FFA, and CE requirements, with expertise in Class 1 medical, Class 2 medical, and Class 2a medical devices.
This role requires proficiency in verification and validation testing, clinical study management, and familiarity with EUDAMED regulations. Additionally, the candidate will be responsible for managing fitness UL requirements to ensure adherence to industry standards and regulations.Key Responsibilities:
Regulatory Compliance Management:
Stay abreast of regulatory changes and updates from UL, FDA, CSA, NSF, FFA, and CE to ensure compliance with applicable standards.
Develop and maintain regulatory compliance strategies for Class 1, Class 2, and Class 2a medical devices.
UL Management:
Coordinate with UL representatives to manage product certification processes.
Ensure products meet UL requirements for safety and performance.
FDA, CSA, NSF, FFA, and CE Compliance:
Manage submissions and interactions with regulatory authorities for FDA, CSA, NSF, FFA, and CE approvals.
Develop and maintain technical documentation, including Design History Files (DHF), Technical Files (TF), and Device Master Records (DMR), to support regulatory submissions.
Oversee verification and validation testing activities to ensure compliance with regulatory requirements.
Coordinate testing activities with internal teams and external testing laboratories.
Clinical Study Management:
Plan and execute clinical studies in accordance with regulatory requirements.
Collaborate with clinical investigators and research teams to collect and analyze study data.
EUDAMED Knowledge:
Stay informed about EUDAMED requirements and ensure compliance with EU medical device regulations.
Prepare and submit required data and documentation to EUDAMED as per regulatory timelines.
Qualifications:
Bachelor's degree in a relevant field such as Regulatory Affairs, Biomedical Engineering, or a related discipline. Advanced degree preferred.
Minimum of 5 years of experience in regulatory affairs within the medical device industry.
Strong understanding of UL, FDA, CSA, NSF, FFA, and CE regulations and requirements.
Experience with Class 1, Class 2, and Class 2a medical devices.
Knowledge of verification and validation testing methodologies.
Proven ability to manage clinical studies and interpret study results.
Familiarity with EUDAMED regulations and submission processes.
Excellent communication, interpersonal, and organizational skills.
Ability to work effectively in a fast-paced, collaborative environment.
This comprehensive job description outlines the key responsibilities and qualifications required for the role of Medical Compliance Manager, emphasizing expertise in regulatory compliance, UL management, verification and validation testing, clinical study management, and EUDAMED knowledge.
The successful candidate will play a critical role in ensuring that our medical devices meet regulatory requirements and maintain the highest standards of safety and quality.
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