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:

This position will provide Regulatory Affairs
oversight to Laerdal to assure FDA and Health Canada medical device and
establishment requirements are met and both Laerdal Medical Corporation (LMC)
and Laerdal Medical Canada (LMCA) remain compliant to medical device
regulations.

This position will provide Quality Assurance
oversight to both the Laerdal Medical Canada (LMCA) facility and LMC New York
facility to assure the Management System is implemented and maintained and will
continue to comply with ISO 9001, ISO 27001, ISO 27701 and other applicable
management system standards.

Position Holder is Accountable For:

Regulatory Affairs Manager, LMC and LMCA:

• Assuring that Laerdal products,
  services and programs distributed in USA/Canada are compliant with
  applicable US/Canadian medical device regulatory requirements.
• Being the FDA Official
  Correspondent (LMC) and Canadian Regulatory Correspondent (LMCA) for
  LMAS and/or LMPRC as Laerdal Medical Corporation.
• Being the Initial Importer for
  Laerdal US/Canada medical device distributions
• Being the FCC US Agent
  - Point of Contact between FCC and LMAS
• Being the US/Canada Field
  Corrective Action (Recall) Coordinator to support and execute the
  corporate FCA process
• Support Corporate Q&R team
  in identification of applicable regulatory requirements for new and
  existing products.
• Support Corporate
  Q&R in the communication with US/Canadian regulatory bodies

Quality Assurance Manager for LMC and LMCA:

• Assuring the Quality System of
  LMC meet FDA/US Quality System regulations, and that the Quality System
  of LMCA meet Health Canada regulations.
• Determine if additional local
  processes/Work Instructions are required to supplement corporate
  processes in order to fulfill US and Canadian Quality System regulations
• Knowledgeable in
  Quality System processes and applicable ISO standards (ISO 9001, ISO
  13485, ISO 27001).
• Assist Corporate QA and RA and
  local teams in implementing process changes through the local
  organization. Assist the affected local teams in their evaluation
  of the need to establish local processes/Work Instructions/training
  materials that would help to effectively implement the corporate process
  (quality system controlled documents, process controls and/or local
  KPIs).

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 and outside
  vendor services associated therewith.
• Regularly communicate State
  Board of Pharmacy licensing updates to senior leadership.

Quality Assurance:

• Facilitate implement of the corporate management system locally
• Maintain the local Quality Systems of LMC and LMCA:
  
  • Facilitate local Nonconformance handling
  • Facilitate
    local medical device Quarantine (returns) dispositions - Use-As-Is or
    Scrap (no locally specified rework/relabeling of medical devices is
    acceptable - only if approved by specification owner, Laerdal Medical
    AS)
  • Facilitate establishing local processes as
    need according to the corporate management system
  • Facilitate
    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. Many corporate process changes will require no
    special local QA implementations/training.
• 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.
• Local ISMS Responsible LMC/LMCA - QA to work with Local ISMS
  Responsible- IT and Corporate Responsible for ISO 27001 Information
  Security Management System/ISO 27701 Privacy Management System during
  implementation, maintenance and improvement at LMC. This role also
  covers Data Privacy processes like DSAR.
• Serve
  as FCC US Agent signing the FCC
  Supplier's Declaration of Conformity for Laerdal Medical AS's FCC
  regulated products sold in US..

As
AGILE Site Manager:

Serve as US/Canada Site Manager for AGILE: Responsible for training new US/Canada AGILE users.

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

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.