Manager, Regulatory Affairs

ComplianceComplianceOtherRemoteLeadTeam 1,001-5,000Since 2006H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

127 days ago

Salary

$127K - $165K / year

Seniority

Lead

Bachelor Degree8 yrs expEnglish

Job Description

Manager, Regulatory Affairs

iRhythm Technologies, Inc.

• Developing and executing regulatory strategies for new and modified medical devices in line with business objectives • Manage regulatory associates as needed, responsible for team’s work planning, guidance, execution and talent development • Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products • Key Regulatory SME and review & approve advertising and promotional materials to ensure regulatory compliance • Regulatory strategy and processes for product life cycle management • Lead EU MDR Technical Documentation and other international submissions for both wearable devices and SaMD • Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed • Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance • Preparing international and domestic regulatory filings/registrations in line with established project timelines • Interacting with regulatory authorities during the development and review process to ensure submission clearance • Review and approve product design changes to maintain regulatory compliance for significant changes • Author or revise SOPs to improve regulatory compliance within the Quality System • Monitoring the impact of changing global regulations on submission strategies & registrations • Support external and internal audits • Perform other regulatory-related duties as assigned.

Job Requirements

  • BA or BS degree in engineering, life sciences, or a related field required
  • > 8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor’s degree
  • 6 years minimum of US and/or EU regulatory affairs experience with a Master’s degree
  • Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards
  • Software as a medical device (SaMD) experience required
  • New product development experience required
  • Authorship of 510(k)s and experience with management of FDA reviews to gain clearance required
  • Demonstrated competency in developing risk based regulatory strategies required
  • Wearable medical device experience preferred
  • Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred
  • Audit support experience preferred
  • Strong project management skills
  • Exceptional problem-solving skills
  • Exceptional organizational skills
  • Exceptional communication (written and oral) skills
  • Willingness to travel when required, approximately 5-10%

Benefits

  • medical, dental and vision insurance
  • paid holidays
  • paid time off
  • 401K (w/ company match)
  • Employee Stock Purchase Plan
  • annual organizational/cultural committee events

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