Long standing relationships
Zenopa develop strong working relationships with our clients, which means we understand their company and cultural values.
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
Please login or register now for full details of this job.
Zenopa develop strong working relationships with our clients, which means we understand their company and cultural values.
Zenopa operate a Quality Management System (QMS) and we're audited to ensure an excellent quality of service.
We thoroughly prepare you for all interviews and obtain full, constructive feedback after you've met the client.
Zenopa provide a constant service. There will always be someone at the end of the phone to answer your questions.
We will always provide you with honest, professional advice and fully understand your career needs.
Our Customer Service standards are extremely high. We are highly recommended by 96% of clients and 98% of candidates.
For a salary applicable to you, please liaise directly with your respective Zenopa consultant.
So that when internet jobs searches are undertaken, Zenopa generates a min and max salary range. This range is just an industry based estimate, it does not represent the clients internal salary bands.