Manager, QA and Regulatory Affairs - Wappingers Falls, NY

May be eligible for hybrid work arrangement and 4 day compressed workweek upon fully onboarded and meeting all expectations

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.
• 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..

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 - $105,000