Aktuelle Jobs im Zusammenhang mit Quality and Regulatory Affairs Lead - Frankfurt am Main, Hessen - CM Medical Recruitment


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Quality and Regulatory Affairs Lead

vor 2 Monaten


Frankfurt am Main, Hessen, Deutschland CM Medical Recruitment Vollzeit
CM Medical Recruitment is seeking a highly skilled Quality and Regulatory Affairs Lead to oversee the company's EMEAI warehouse facilities and third-party distributors across the region. The successful candidate will ensure high-quality and compliant distribution of medical devices, pharmaceuticals, and combination devices.

**Key Responsibilities:**

* Support re-labelling activities and ensure release disposition of relabelled products
* Collaborate with Operations, Supply Chain, Business System Group, and EHS functions on development and execution of distribution management strategy
* Monitor distribution performance and quality to ensure desired levels of performance and prompt escalation of identified trends/concerns
* Advise on areas of compliance risk and recommend appropriate corrective and preventive actions
* Partner with Distributors to support product complaints investigation in accordance with established procedures
* Support Medical Safety with Vigilance, MDRs, and other regulatory reporting activities
* Host Regulatory and Notified Body inspections and other compliance audits including corporate audits

**Requirements:**

* Current, in-depth knowledge of FDA, European Union, and other international regulatory and quality requirements pertaining to medical devices
* Fluency in German and English

**About CM Medical Recruitment:**

CM Medical Recruitment is a leading recruitment agency specializing in the medical device industry. We are committed to providing exceptional recruitment services to our clients and candidates.