Design Quality Lead DHT (Digital Health Technology)

Job title: Design Quality Lead DHT (Digital Health Technology)

Location:

New Haven, CT, Hybrid (3 days onsite / 2 days remote) Contract duration: 12 months Interview - 2-round virtual interview This is what you will do: The primary purpose of this position is to build internal QMS oversight for AI DHT or AI SaMD development with business partnering

AI DHT / AI

SaMD companies. The business partner (BP) shall develop the technologies and shall execute processes in line with their own QMS. The BP shall also complete the regulatory submissions for the product unless Client decides to perform this role. The DHT Q shall ensure key quality criteria are in place in the Client QMS so that development work can start and oversee the BP design control activity to ensure key quality milestones are achieved for EU and US markets. The DHT Q is the quality liaison between Diagnostics Strategy & Development group (Product Development), Medical Device Quality and Regulatory Affairs to ensure internal and partner compliance with Quality Standards, Regulations and Design control activities for the clinical and commercial development of

AI DHT / AI

SaMD products. The role enables efficient communication for decision making related to quality and product development. This is a hybrid position, requiring 3 days office attendance at either the Client New Haven or Boston office.

You will be responsible for:

Responsible for creating QMS related SOPs and/or guidance documents for the collaboration with BP to meet requirements of

ISO 13485

2016, IVDR, IEC 62304, FDA Part 820 QMSR. Clearly identify roles and responsibilities for Client and BPs for device technical documentation generation including DHF and Device Clinical Performance. Support R D Quality in the supplier qualification process (Operational Due Diligence) during the onboarding of BP for clinical development. Responsible for ensuring that BP development process and regulatory strategy for such devices and systems comply with all WW regulatory requirements. Quality responsibilities for BP for which the DHT Q shall have oversight shall be documented in a BP quality oversight plan. Identification of any known or new gaps to SOPs. Support product development create Quality Plans or document mitigations to ensure gaps and risks are addressed appropriately ensuring project deliverables are compliantly kept on track. Liase with •partners to leverage existing resources, processes and procedures. Where appropriate involve •partners to support program deliverables. Device BPs shall supply Client with milestone development summary reports per the quality oversight plan. The DHT Q shall be responsible for Quality oversight, participation in the review and approval of key deliverables including Design Development, Regulatory submissions, Design Transfer activities including CAPA, Risk Management, Change control, Design Reviews. Responsible for providing input and review of Design Control deliverables e.g. per

ISO 13485

2016 Section 7.3 Design and Development and

IEC 62304.

Assist in quality review of Regulatory submissions and response to queries. Supports regulatory inspections and compliance. Supports cross functional activity to ensure audit readiness is in place for all aspects of the product lifecycle. Other duties as assigned.

You will need to have:

B.Sc. / B Eng degree in Engineering or Science or equivalent experience in regulated industry. Preferable 7 years + cGMP experience within quality in a medical device, SaMD R D, ideally clinical phases through commercial Understanding of Medical device development for the full lifecycle starting at the Design Control phases. Knowledge of the regulatory and compliance requirements of design control for

AI DHT / AI

SaMD medical devices (FDA

QSR 21 CFR

Part 820 / ISO 13485 and Regulation (EU) 2017/745). Demonstrated ability in decision making, problem solving and project management. Collaborate, negotiate, influence and lead in a matrix organization Excellent communication and interpersonal skills Proven record in demonstrating agility We would prefer for you to have: Experience in successful development, filing and Producting approval for global regulatory submissions Experience in development of

AI DHT / AI

SaMD and regulatory approval 510(K), De Novo or PMA.