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» Job Vacancy

Chief/Director of Quality and Regulatory Affairs (QARA)


Hours: Full Time
Category: Medical/Pharmaceutical/Scientific,
Location: East Midlands, East Midlands, United Kingdom

Jul 17th
days old


views


applied




Description
Our client, a medical device manufacturer requires a Chief or Director of
Quality & Regulatory Affairs (QARA) who will be responsible for
developing, implementing and maintaining a Quality and Regulatory
strategy and for ensuring Regulatory Compliance in the company’s chosen
markets and all other future expansion markets.
Based in Warwickshire and reporting directly to the CEO, this role will
lead all activities required to secure, maintain and adhere to the
necessary regulatory approvals, including budget responsibility and the
management of an internal team and external advisors, while working
closely with key internal and external stakeholders.
The Chief or Director of QARA will serve as the Management Representative
with respect to ISO13485 and acts as the company’s primary representative
and point of contact with all external regulatory agencies.
Key Responsibilities of the Chief/Director of Quality and Regulatory
Affairs (QARA)
Regulatory & Risk Management
* Lead the process to ensure preparation and submission of a successful
FDA submission in order to obtain (and ultimately maintain)
regulatory clearance for a SC+ system and accessories in the USA
* Manage all activities required to ensure ongoing compliance with FDA
and MDR regulations, including all appropriate international
standards such as ISO13485
* Ensure input into product design & development such that products are
designed in compliance with regulatory requirements and applicable
standards
* Oversee Risk Management process to ensure that suitable solutions are
found whilst not compromising patient safety
* Establish an appropriate Post Market surveillance process that
manages all the required inputs to ensure that it is an effective
process and fully supports design & development activities. This
should also include the Clinical Evaluation summary
* Manage a Post Market Vigilance reporting system to meet all
Regulatory requirements
* Define and implement strategy for future regulatory submissions with
respect to label expansions and/or product improvements
* Ensure maintenance and accuracy of all current technical
documentation supporting regulatory compliance and the Technical File
Requirements/Qualifications
* Degree qualified in a relevant discipline
* Significant relevant experience, including previous track-record
managing and securing Regulatory approvals for complex Class II
medical devices
* Familiarity with the requirements of Code of Federal Regulations
Title 21 (21 CFR 820); Quality Systems Regulations, ISO13485 and
other applicable standards
* Experience in regulatory submissions and resubmissions to a range of
other relevant jurisdictions
* Able to provide evidence of understanding and familiarity with
Programmable Electrical Medical Systems (PEMS) and high integrity
environments requiring multidisciplinary development across
mechanical engineering, software, electronics, system integration,
etc.
* Ability to lead and manage employee and department performance,
creating a culture of highly motivated and high performing
individuals leveraging strong interpersonal and intercultural skills
* Flexible for occasional UK and International travel to meet with
Regulatory Bodies, 3rd party suppliers and other key stakeholders
Total Reward Package
* £100,000+ salary;
* Very lucrative number of valuable share options;
* Excellent Car Allowance;
* A wide range of benefits as expected at this level.
This is a £200,000 total reward package
Applications required ASAP as interviews will commence immediately.
In return, you can expect an £excellent total reward package including
£salary, a very lucrative number of valuable share options, and a work
based culture that any employer in this sector will be hard pressed to
beat
Company
Company: CV Library Ltd

Further Information
Reference: 208267864/emj92121
Posted: 17 Jul 2018, 10:22
Visa Required: Applicants must be eligible to work in the specified location








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