Regulatory Affairs Manager

Remote

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BrightInsight, Inc.
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Posted 1 week ago

With over 400M connected medical devices worldwide and the value of the healthcare Internet of Things (IoT) market valued at $163 billion, it’s no surprise that venture funding in the Digital Health space has hit record highs year after year. What’s clear is that all of healthcare’s future products – medical devices, combination products, wearables, Software as Medical Device and more – will all be digitally driven.

A leader in the digital health space is BrightInsight, the VC-backed Silicon Valley startup that provides the leading global regulated IoT platform for the world’s top biopharma and medtech companies.

We are a team of experienced professionals who have first-hand experience building and scaling digital health solutions within the regulated healthcare space. We are passionate about what we do and wholeheartedly believe in our vision to transform patient outcomes globally by bringing the power of digital technology to healthcare.

Since launching the BrightInsight Platform in 2018, we have secured a number of top-tier customers, including announcements with 4 of the world’s top 20 biopharma companies. Our award-winning platform was selected as the “Best IoT Healthcare Platform” in the 2019 MedTech Breakthrough Awards, Google Cloud’s Partner of the Year for Healthcare for two consecutive years, was featured as the cover story for CIOReview Magazine’s “20 Most Promising Biotech Solution Providers 2019, and was included in The Journal of mHealth's “2020 Global Digital Health 100”.

If you enjoy working with solution-oriented, driven colleagues in an agile, beaurocratic-free environment, then come join us at BrightInsight.  

In this role, you have the opportunity to

  • Develop and implement regulatory strategies, oversee all aspects of regulatory submission development, and interface with health authorities for SaMD (Software as a Medical Device), companion diagnostic devices, and other digital health software.
  • Develop, modify and execute company regulatory
  • Ensure that project regulatory timelines are established and met.
  • Perform regulatory assessments and establish plans for global product submissions/launches.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Conduct pre-submission meetings with regulatory authorities.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Develop or conduct employee regulatory training

Responsibilities

  • Driving improvement in regulatory aspects of the Quality System, developing processes and detailing procedures to ensure an effective Quality System.
  • Reviewing and recommending changes for design process to maintain quality and regulatory compliance
  • Providing mentorship on global compliance, such as CE Marking and product registrations, clinical evaluations, ISO 13485 and compliance with FDA’s guidance documents etc.
  • Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.
  • Preparing and filing 510(K), PMA, or other regulatory submissions, registrations, listings, etc.
  • Develop and implement regulatory strategies for software medical devices and companion diagnostic devices across a range of therapeutic areas.
  • Providing regulatory support to software development project teams.
  • Conducting regulatory training to the BrightInsight team.

Required Skills and Experience

  • A minimum of 5 years of experience in a regulated and technical environment in a medical device company (FDA Class III experience preferred).
  • Experience with successful preparation and submission and clearance/approval of Technical File, Design Dossiers, 510(k), PMA, and international registrations.
  • Knowledgeable of MDD and MDR, IVDR, ISO13485, IDE and 510(k) premarket notification.
  • Excellent knowledge of regulations (21CFR), FDA law and CE marking
  • Experience preparing for and participating in pre-submission meetings.
  • BS Degree in science (biology, biochemistry, chemistry, microbiology, immunology, pharmacology), engineering, medical-related or health-related field preferred
  • Regulatory Affairs Certification (US) through RAPS preferred
  • Strong working knowledge of FDA regulations, including knowledge of software as a medical device development process.
  • Strong attention to detail and well-developed analytical thinking skills
  • Strong project organization and time management skills, including the ability to prioritize multiple challenging project timelines while ensuring all deadlines are met
  • Ability to take initiative and work autonomously without significant direction, implementing judgment to resolve objectives.
Job tags: Clearance Compliance HTML Training