Manager, QA and Regulatory Affairs

Manager, QA and Regulatory Affairs

Laerdal Medical Benefits Include:

• Generous PTO & Holidays
• Hybrid and Compressed Work Week (for operations-based roles only)
• Comprehensive Medical, Dental, and Vision
• HSA & FSA Account Options, with employer HSA contribution
• 401k with Employer Match & Profit Sharing
• Tuition Reimbursement
• Wellness Reimbursement Program
• Professional Development Opportunities
• Pet Insurance
• Subsidized Cafeteria in NY based office

Position Overview:

The Manager, QA and Regulatory Affairs will ensure regulatory compliance for Laerdal Medical Corporation (LMC) and Laerdal Medical Canada (LMCA), meeting FDA and Health Canada requirements for medical devices and establishments. This role will also oversee Quality Assurance for LMCA and the LMC New York facility, ensuring the Management System aligns with ISO 9001, ISO 27001, ISO 27701, and other applicable standards. This position is critical to maintaining compliance and supporting Laerdal's mission of advancing healthcare and patient safety.

Responsibilities:

Regulatory Affairs:

• Responsible for Adverse Event
  reporting (eMDR) to FDA and Problem Reporting to Health Canada following
  notification through corporate AGILE AE process
• Responsible for US FDA's medical
  device listings/registrations, establishment filings and GUDID
  registrations, including required updates (following product
  in/out-phasings, introduction of new medical devices).
• Responsible for Health Canada
  Class I MDEL Establishment licenses and all Class II medical device
  licenses. To work with Consultants on these annual renewals.
• Responsible for hosting US FDA
  Audits of LMC and facilitating responsive Corrective Actions to the
  Quality System.
• Responsible for hosting Health Canada audits of LMCA
  and maintaining their Quality System.
• Support local SMS team members in
  all new medical device in-phasing of any new medical devices into the
  USA. This assures all US/FDA Regulatory requirements have been met
  prior to new medical device/controlled product sales and
  distributions.
• Responsible for reporting Laerdal
  medical device Recall actions to FDA and Health Canada, or for other
  products to other agencies (i.e. CPSC).
• Assist Corporate RA in developing
  corporate Regulatory Plans for new controlled products and RA processes,
  as needed.
• Directly manage LMC's State Board
  of Pharmacy licensing process, compliance requirements and outside vendor
  services associated therewith.

Quality Assurance:

• Facilitate implement of the corporate management system locally
• Maintain the local
  Quality Systems of LMC and LMCA:
  
  • Facilitate local
    Nonconformance handling
  • Facilitate establishing
    local processes as need according to the corporate management system
  • Plan and conduct annaul local
    Internal Audits of LMC/LMCA Quality System
  • Facilitate implementation of
    corporate process changes with local teams, as needed. Determine if
    additional clarifications or local SOPs/Work Instructions and/or training
    materials are desirable for local implementation.
• Host ISO 9001, ISO 27001, ISO 27701 (cohost w/ IT)
  External Audits of LMC and LMCA and facilitate responsive Corrective
  actions
• Facilitate Management
  System Review meetings for LMC and LMCA
• Local Field Corrective
  Action (Recall) Coordinator for LMC and LMCA. Facilitate and/or
  verify the affected product Distribution listings are correct for USA and
  Canada. Notify Corporate Regulatory Affairs and/or their designee of
  relevant Recall/FCA information, as needed.
• Locally assist Global
  Supply Chain/Logistics with corporate Stop Shipments and rework - for all
  products, as needed
• Assure new hires receive
  training on Laerdal's Management System (via People on-boarding process)
  and periodically provide Management System refresher training to all
  employees, as needed
• Coordinate with local
  ISMS Responsible LMC/LMCA to report out at Management review to cover ISO
  27001 Information
• Security Management System/ISO 27701 Privacy Management
  System
• Serve
  as FCC US Agent signing the FCC
  Supplier's Declaration of Conformity for Laerdal Medical AS's FCC
  regulated products sold in US

Requirements:

• Bachelor degree in Life/Clinical sciences or Engineering
• Quality/Regulatory experience (=> 5 yrs) or Medical Device Regulation Certificate (i.e. Regulatory Affairs Professional Society (RAPS) - Regulatory Certificate (i.e. RAC)
• Competent in US and Canada medical device Regulations - Recalls, Quality Systems, GUDID, Internal Audits, and Device and Establishment registrations
• Competent in ISO 9001, ISMS, Data Security, Quality System requirements and other local Regulations - host External Audits
• Competent in Assessing medical device adverse events - MDR/MPR assessments and reporting to US and Canada
• Communication and Teamwork: SMS to/from Corporate and manufacturer
• Set Direction & Deliver Results: assure local Management System Reviews, establishment and device registrations and Internal Audits are planned and completed

Salary Range: $95,000.00-$105,000, eligible for 9% annual bonus

Please note that this range does not include any other compensation or benefits that an individual may be eligible for. The salary offered depends on a variety of factors, which may include, but not limited to; the qualifications of the individual applicant for the position, location, level of education attained, and/or professional certifications, years of relevant experience, special skills, etc.

Laerdal Medical Corporation is committed to provide equal employment opportunities to all applicants and employees without regard to race, color, citizenship status, religion, sex, sexual orientation, gender identity, martial status, age, genetic information, status as an individual with a disability, status as a protected veteran or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity.