• Privately owned Global Medical Device Manufacturer
• Attractive employee benefits
• Strong inclusive culture that values our people
The Regulatory Reporting Team Leader is responsible for the planning and coordination of activities related to the handling of reportable customer complaints, recall action and post market vigilance trending.
This position plays an integral role in the communication to local and international regulatory authorities and sponsors in relation to reportable events and recalls.
You will be leading a high-performing team where you can establish positive working relationships with internal and external stakeholders.
At Cook Medical, we are passionate about the work that we do in making a difference to patient lives around the globe. We treat everyone with respect and encourage our employees to be transparent, through open and honest communication and being appreciative of individual contribution.
• Ensure personal and team compliance with Cook values, quality system procedures, policies and relevant medical device standards and regulations.
• Maintaining medical device vigilance and recall quality system procedures to ensure compliance to applicable regulatory requirements.
• Assessment of local manufacturer complaints for reportability to the TGA and to global regulatory authorities.
• Assessment of complaints received as an Australian Sponsor for reportability to the TGA.
• Ensure complaints are reported as per the timelines required by applicable regulations.
• Submit initial, follow-up and final device incident reports to the regulatory authorities within the required timeframes.
• Provide additional information regarding reportable complaints to regulatory authorities as required.
• Liaise with other Cook companies regarding reportable complaints as required.
• Provide guidance and supervision to team members regarding processing of reportable complaints.
• Liaise with the Heads of QA, RA and Medical Affairs regarding potentially reportable events.
• Preparation of post market annual reports for Australian manufactured and sponsored Class III and IIb devices and submission of these reports to the TGA.
• Support the recall committee to determine the regulatory requirements for initiation of recall.
• Preparation, submission, follow up and closeout of recall, product defect correction, hazard alert, defect alert and FSCA notices to the TGA and applicable global regulatory bodies for Australian Manufactured products.
• Preparation and submission of recall, product defect correction, hazard alert, defect alert notices to the TGA as an Australian Sponsor.
• Maintain oversight of all recall action progress and assess the effectiveness of the recall strategy as per Quality System requirements.
• Lead all other recall related communications with applicable regulatory bodies.
• Liaise with other Cook manufacturers regarding Australian recall notices.
• Tertiary qualification in a technically related field i.e. Science, Engineering etc. is essential
• Basic knowledge of quality system standards (e.g. ISO 9001, or ISO 13485) is essential
• Good understanding of vigilance regulatory requirements for Australia, the USA and EU countries is essential
• Intermediate Microsoft Office proficiency (Excel, Word) essential
• Supports others to develop, and acknowledges their strengths and accomplishments
• Leads by example and guides the performance of others
• Allocates time and resources effectively and efficiently to achieve outcomes
• Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards
• Must maintain company quality and quantity standards
• Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Seeks opportunities for innovative and improved approaches to delivering results
Cook Can Offer:
• Stability of a long-established company
• Values recognition and service awards
• Monthly bonus based on global sales performance
• Top Hospital Private Health Cover for immediate family
• Subsidised cafeteria
• Flexible start/finish times
• Ongoing training and development
• Strong inclusive culture that values our people
Candidates applying to this role must be a permanent resident or citizen of Australia.
This role is to commence as soon as possible, and shortlisting will commence immediately.
About Cook Medical:
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials, and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently.
Headquartered in the United States, we also have manufacturing locations in Denmark, Ireland and Australia. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities.
As a global, modern company we ensure that our company values reflect our everyday business practices, staying true to what Bill and Gayle Cook started in 1963.
At Cook Medical, we embrace diversity and inclusion. We understand that everyone can offer a unique perspective and can contribute their own ideas to improve how we work. We strive to create an environment where our employees can feel empowered to make decisions and can bring their full, authentic selves to the workplace.
We are seeking conscientious employees who align with our values, and we encourage people of all genders, races, ages and abilities to apply for roles within our organisation.
For more information please visit www.cookmedical.com.au/careers
The future of medical care has never been more exciting.