Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.
Regulatory Affairs Manager - Cairo, Egypt
As a Regulatory Affairs Manager you will be responsible for coordinating and preparing document packages for regulatory submissions from all areas of company, internal audits and inspections. You will be compiling all materials required in submissions, license renewals and annual registrations. One of the key focuses of the role will be recommending changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Our Regulatory Affairs Manager will be also monitoring and improving tracking / control systems as well as keeping abreast of regulatory procedures and changes. You will have direct interaction with regulatory agencies on defined matters.
The Regulatory Affairs Manager is expected to either be located already in Cairo, or to be considering and willing to relocate to Cairo.
Key Responsibilities of Regulatory Affairs Manager:
• To manage the regulatory department and develop processes so that all regulatory action / product registration etc. are done in a timely fashion and in compliance with the local and company requirements
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Guiding, directing and motivating subordinates - providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
• Interpret regulatory and quality rules or rule changes and ensure that they are reported to management and captured through corporate policies and procedures.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Obtain and report updated information regarding domestic or international laws, guidelines, or standards.
• Support regulatory activities with Business Units (BU’s)
• Interface with the local competent authorities
• Ensure regulatory and quality compliance to local country/ ie regulation as well as company requirements
• Maintain up-to-date knowledge of Medical Devices Regulations and Guidelines for licensing of products for the countries responsible for.
• Define the regulatory licensing strategy and identify required elements for each submission
• Ensure proper elements of product submissions are collected from BU’s, prepared, and submitted in a timely manner
• Ensure full execution of FA recall based on the company plan and country regulation
Job Details
| Date Posted: | 2015-09-29 |
| Job Location: | Cairo, Egypt |
| Job Role: | Healthcare/Medical |
| Company Industry: | Medical/Hospital |
Preferred Candidate
| Career Level: | Management |
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Regulatory Affairs Manager - Cairo, Egypt
Regulatory Affairs Manager - Cairo, Egypt jobs
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