Job Description• Ensure departmental/divisional compliance with existing laws, regulations and requirements by leading and supporting multifaceted and more complex cross functional activities that may impact a range of critical business processes aligned directly to key strategic initiatives.• Develop project plans and recommendations in support of Departmental/Divisional compliance ...
Seeking track record in oversight of regulatory submissions for the US, EU and ROW registrations and Quality System compliance processes such as CAPA, change orders, internal audits and adverse issues.
Requires 4+ years of experience in Medical Device Regulatory Affairs for an ISO 13485 environment.
*** Preparing and filing regulatory submissions including registration of ...
Directors, Medical Affairs; Good understanding of the principles of ICH GCP and regulatory requirements. Proven experience in clinical trials with a strong...
Aug 17 - United States
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