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Regulatory Affairs Manager - Medical Devices

Company: Job Juncture
Location: Covington
Posted on: March 27, 2020

Job Description:

Leading medical devices company seeks a Regulatory Affairs Manager to manage regulatory submissions globally. Requirements for Regulatory Affairs Manager Bacheloraposs degree, preferably in a technical discipline, like biology, medical sciences, materials science. 4+ years work experience in medical device regulatory affairs, with successful FDA and EU-notified bodies submission experiences. Strong working understanding of US, EU, Canada regulations on medical devices Experience with medical device product registration and licensing is required Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications. Strong communications skills, oral, written and electronic The ability to handle multiple competing projects effectively and work independently with international oversight Good record keeping skills The Regulatory Affairs Manager will Prepare domestic and international submissions, including CE-mark dossiers, for new products and product changes. Author dossier content for new device registrations and variations Communicates directly with US and international affiliates and regulatory personnel. Represent regulatory on product development teams, developing and executing regulatory plans, and providing regulatory impact information for project options. Provide support to new and currently marketed products including labeling advice and post market follow up activity requirements. Update of Technical Files and Design Dossiers as required along with developing strategy and creation of change notifications to regulatory agencies. Assess and respond to deficiencies issued by health authorities in response to new registrations, variations, renewals, etc. Provide regulatory assessments for manufacturing change controls Document regulatory activities and approvals to support global market authorizations. Ensure files maintain compliance with regulatory requirements. Acts as a liaison with other departments, e.g., Quality, RD, supply chain, marketing, and medical affairs for support of major initiatives. Support internal and external auditsinspections as required (EU notified bodies, FDA, etc). Responsible for ensuring company compliance with Federal, State, and local regulations, policies, procedures and international regulations (e.g. EU-MDR, MDSAP, etc) Author and train on regulatory related standard operating procedures and work instructions as required.

Keywords: Job Juncture, Covington , Regulatory Affairs Manager - Medical Devices, Executive , Covington, Kentucky

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