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Job Title: Senior Regulatory Affairs Associate
Job No.: 600195
Department:
Quality Clinical & Regulatory
Work type:
Permanent
Location:
Sydney
Cochlear is the global market leader in implantable hearing solutions and is a top 100 company on the ASX. Our cochlear implant systems comprise high-reliability implantable devices together with external sound processors and connectors to provide hearing for people with profound hearing loss. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives.
Key Responsibilities
We are seeking a Senior Regulatory Affairs Associate to join our corporate Quality, Clinical and Regulatory department at our global headquarters located on campus at Macquarie University. Reporting to the Head of Regulatory Affairs, this role works with product development and manufacturing engineers to review and improve technical documents for regulatory submission. This role is responsible for reviewing design history files for pre-market approval of new products and technical documents detailing post-market changes to approved products, including manufacturing process changes.
In this permanent role you'll have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your technical and regulatory knowledge to help teams involved in product development and manufacturing prepare clear and logical technical documentation that is suitable for submission to regulators. You'll know you've been successful in this role when you've anticipated questions from regulators and helped to improve the clarity of technical documents. This is a rare opportunity to gain detailed, technical regulatory experience with a leading manufacturer of medical devices for global markets.
Key Requirements
Proven experience reviewing and editing technical documents to ensure clarity, accuracy, completeness, logical flow and structure.
Experience working with formal change control processes and approval work-flows for medical devices or pharmaceutical products.
Ability to interpret regulations and apply knowledge of quality systems standards such as ISO13485 and CFR21 Part 820.
Experience working in highly regulated industries such as medical devices or pharmaceuticals.
Understanding of technical specifications and protocols used to test devices to international standards.
Engineering degree or technical experience that would enable you to understand the technical detail in documents prepared for regulatory submission.
Experience reviewing design history files or change notifications to prepare them for regulatory submission would be ideal.
Working for Cochlear:
Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear's global headquarters is located on the campus of Macquarie University, Sydney, Australia to enable links to world leading hearing science research. A success story in the commercialisation of R&D, Cochlear has a 70% share of the global market, employs more than 2,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 250,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution. Cochlear can offer:
The Work - A high impact job supporting world leading technology
The Organisation - A global leader in active implantable medical device hearing technology
The Opportunity - To make a difference to the quality of people's lives
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlearcareers.com for more information.
Working at Cochlear's Global HQ:
High-tech facility designed to facilitate collaboration.
Close to train (Macquarie University station) and buses.
Secure storage and change facilities for cyclists and motorcyclists.
Access to facilities on the Macquarie University campus.
Relocation to Australia
Australia offers the opportunity for a wonderful life style with a warm climate and high standards of living and education. For international candidates who meet the highest standards required for this role Cochlear will provide international relocation support. Candidates will need to meet the visa requirements stipulated by the Australian Government. Cochlear will provide visa sponsorship and will meet the costs of the visa application submission.
To Apply:
http://careers.cochlear.com/jobDetails.asp?sJobIDs=600195&lCategoryID=&lWorkTypeID=&lLocationID=4667%2C4669%2C4678%2C6015%2C7831%2C7832&lDepartmentID=&stp=AW&sLanguage=en
Deadline: 14th Jan 2013
