Regulatory Affairs Director

🕒 vor 8 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $150.000 - $175.000 / Jahr

⏰ Vollzeit

🔴 Experte

🚔 Compliance

Jetzt Bewerben

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VitalConnect

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2011

📡 Telekommunikation

Healthcare • Telecommunications • Technology

VitalConnect ist ein Unternehmen für Medizintechnologie, das sich auf Lösungen für die Fernüberwachung von Patienten spezialisiert hat, insbesondere im Bereich der Herzgesundheit. Ihr Flaggschiffprodukt, der VitalPatch RTM, ermöglicht das Echtzeit-Streaming von Vitalparametern, so dass medizinische Fachkräfte den Zustand der Patienten bequem von zu Hause aus überwachen können. VitalConnect ist insbesondere im Kontext von COVID-19 relevant, da ihre Technologien eine sichere Patientenüberwachung ermöglichen und die Exposition von Pflegekräften minimieren. Der innovative Ansatz des Unternehmens im Bereich der Telemedizin hat es zu einem wichtigen Akteur bei der Optimierung der Patientenversorgung gemacht.

Beschreibung

• Responsible for regulatory affairs activities such as regulatory submissions, registrations and listings. • Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. • Assist in creation and maintenance of regulatory files. • Assist with post-market activities. • Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including device submissions in USA, Europe and other countries. • Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. • Maintain regulatory files. • Maintain and update regulatory authorizations, such as 510(k)s, medical device licenses, certificates, and CE Technical Files for EU, etc. • Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. • Support approval in other regions as required. • Assist in preparing response to regulatory authorities’ questions within assigned timelines. • Stay abreast of regulatory procedures and changes in regulatory climate. • Assess device related incidents/complaints for medical device reporting requirements. • Compile and submit reportable events to relevant regulatory authorities in timely manner. • Handle recalls and field actions, if required. • Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

🎯 Anforderungen

• Bachelor’s degree in Engineering or Science or related scientific discipline. • 4 years minimum experience in a medical device environment • Working knowledge of regulations, standards and guidelines related to regulatory affairs • Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills • Excellent written and verbal communication skills with the ability to listen, articulate and advocate • Proactive, high performance, result oriented and manage projects with ethical integrity • Technical system skills (e.g. MS office applications, databases, efficient online research) • Manage multiple projects and deadlines • Ability to identify compliance risks and escalate when necessary • Demonstrate both creative and critical thinking skills.

🏖️ Vorteile

• medical • dental • 401K retirement plan