Regulatory Affairs Director

🕒 June 2

🏄 California – Remote

🏄 California – Remote

💵 $150k - $175k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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VitalConnect

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

📡 Telecommunications

Healthcare • Telecommunications • Technology

VitalConnect is a healthcare technology company that specializes in remote patient monitoring solutions, particularly for cardiac health. Their flagship product, the VitalPatch RTM, enables real-time streaming of vital signs, allowing healthcare providers to monitor patients' conditions from the comfort of their homes. VitalConnect is especially relevant in the context of COVID-19, as their technologies facilitate the safe monitoring of patients while minimizing caregiver exposure. The company's innovative approach in telehealth has made it a key player in optimizing patient care.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• medical • dental • 401K retirement plan