Sr Regulatory Affairs Manager

Senior Manager, Regulatory Affairs (remote)

Focus: Global Regulatory submissions with emphasis on U.S. FDA

Products: medical wearable and artificial intelligence technologies

We combine wearable biosensing technology with powerful cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line monitoring for patients at risk for arrhythmias. We have already helped over 4 Million patients!

As Senior Manager, Regulatory Affairs with a fast growing, AI driven software and wearable
hardware medical device company, you will be responsible for leveraging your regulatory
expertise to strategically and creatively guide your team in gaining and maintaining device
registrations across portfolio in partnership with cross-functional teams. You and
your team will assess market requirements, develop FDA and global product RA strategies, and
guide teams from design to submission and through successful regulatory reviews.

Responsibilities:

• Provides the front line leadership to the global Regulatory Affairs Team covering
  regulatory operations, device change assessments and submissions, as well as
  regulatory intelligence.
• Lead FDA 510(k) submissions, including wearable devices, as well as, Artificial
  Intelligence (AI) Software as Medical Device (SaMD).
• Contribute to EU MDR Technical Files and other international submissions for both
  wearable devices and SaMD.
• Guides the development of global, regional, and multi-country regulatory strategies
  supporting portfolio and new product pipeline.
• Monitors the regulatory landscape to anticipate and prepare for emerging regulatory
  obstacles; influence the regulatory landscape through partnerships with industry
  working groups, trade associations, and communications with regulatory agencies.
• Leads preparations and interactions with regulatory authorities, including the FDA,
  regarding device clearances/approvals.
• Represent Regulatory Affairs on significant company projects and provide strategic and
  tactical regulatory guidance to cross-functional teams including R&D teams.
• Review and approve product design changes to maintain regulatory compliance for
  significant changes.
• Author or revise department procedures to improve regulatory compliance of the
  Quality System.
• Review and approve labeling, advertising, and promotional materials.
• Support product health hazard evaluations, recalls and communications for
  internationally commercialized products.

Required Qualifications:

• >8 years of regulatory affairs experience with a Bachelor's degree (B.A./B.S. required) in engineering or relevant scientific field;

• SaMD/MDSW, wearable, and OTC medical device experience required
• AI/ML and/or software as medical device experience required
• Familiarity with global medical device regulations; 21 CFR 820, EU MDR, UKCA, ASIA PAC
  etc. highly preferred
• Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366,
  GDPR, HIPAA and other international regulations/directives/standards highly preferred
• Product development or sustaining/life cycle management experience required