Nordberg Medical ยท 5 days ago
Director - Regulatory Affairs US
United States
Full-time
Remote
Director/Executive
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Responsibilities
Achieving the company goals for FDA PMA approvals.
Supporting and leading the process through regulatory discussions & regulatory adherence with FDA and regulatory partner in the US.
Driving and overseeing CRO activities to align with company objectives.
Overseeing clinical requirements for ongoing clinical studies in the US as part of the FDA application process.
Ensuring clinical data integrity and making sure study timelines are consistently met.
Building and maintaining relationships with key industry stakeholders to support our regulatory and clinical initiatives.
Qualification
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Required
Expertise in FDA PMA approval process
Understanding and compliance with regulatory processes
Experience in leading regulatory discussions with FDA
Ability to drive and oversee CRO activities
Knowledge of clinical requirements for FDA application process
Ensuring clinical data integrity
Ability to meet study timelines
Experience in building and maintaining relationships with industry stakeholders
Company
Nordberg Medical
Nordberg Medical develops biomaterial-based products, specializing in anti-aging solutions and fully absorbable implants.
Founded in 2017
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
