QA/RA Manager (Medical Devices)

Hobson Prior are currently seeking for a QA/RA Manager (Medical Devices) to join a fantastic diagnostics organisation on a permanent basis located in Boston. Our client is focused on driving change across the international healthcare landscape.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will assist with the quality & regulatory method by appropriate prioritisation of actions, reply to time-crucial actions in a timely manner, and exhaustive documentation of necessary evidence and crucial decisions in the quality management system.
• Guide regional complaints management and post market surveillance actions.
• Assume responsibility for regional CAPA management which involves mediating with any other areas of the business on their critical actions.
• Enable the suitable documentation of procedures in the quality management system.
• Guarantee that good GDP and data integrity principles during the organisation.
• You will guide the change management procedure in the quality management system.
• Support the supplier management actions, for example questionnaires and supplier corrective actions.
• Exhibit the quality objectives in all actions and mediate with the broader business functions.
• Responsible for assisting the international regulatory team with product regulatory proposals.
• Any other assigned duties.

Requirements:

• Abilities in strategising and spotlighting actions to assist the quality & regulatory method efficiently.
• Capable of guiding by example and inspiring coworkers across various functions and regions.
• Experience with ISO 9001 / 13485, MDR and any other international medical device legislation for quality management systems.
• Acquaintance with multiple maturities of QMS and eQMS platforms.
• Ability to implement pertinent quality management system actions such as CAPA, change control, risk management, documentation.
• Prior involvement working with shareholders across the business.
• Comprehension of post market surveillance and past implementation within an international environment.
• Familiarity with Medical device and IVD implementations in the USA/EU/UK and AUS would be ideal.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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