Quality Lead - Medical Devices

PRODUCT PORTFOLIO:
IV Disposables

SCOPE:
Worldwide: you will proactively address compliance needs for products and processes in EMEA and other geographies outside the U.S. (as applicable).

ROLE:
This role provides post market quality direction and support for the portfolio of products. Special focus will be given to overseeing activities relating to IV Disposables, supporting Medication Management Solutions (MMS) OUS and facilitating processes. The incumbent will be responsible for managing day-to-day post market quality activities such as evaluation and notification of adverse incidents (vigilance), competent authority inquiries and follow up, field action processes and activities, and metrics for Quality Management System input and other reporting purposes.

As Quality Compliance Lead, you will have the following:

EDUCATION/EXPERIENCE:
· Degree level or equivalent qualification in a relevant subject area; demonstrated medical device clinical knowledge and experience would be beneficial
· A minimum of 5 years' experience in medical device QA and/or RA, preferably in compliance-based roles
· Experience in healthcare industry or medical device manufacturing

COMPETENCIES:
· In-depth knowledge of European Medical Device Directive and the new Medical Device Regulation;
· Demonstrated ability managing direct reports as well as facilitating activities being performed by individuals in a broader matrix organization;
· Strong understanding of Adverse Event handling (vigilance reporting) and FSCA reporting in accordance with applicable MEDDEV guidance and international geography regulatory requirements;
· Hands-on experience dealing with competent authorities and other regulatory bodies;
· Project management and/or process change (process improvement) experience with the ability to simultaneously work on multiple projects/activities of various disciplines

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