Investigations Specialist (Medical or Surgical Incidents)
Salary undisclosed
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Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. 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.
Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.
The Opportunity
The Investigations Specialist will be responsible to investigate medical or surgical incidents involving Cochlear’s devices globally and link findings to Product Risk Management and Post Market Surveillance processes to support visibility and drive improvements to Cochlear products and the use of them by healthcare professionals.
The role will support alignment between post market experience and risk management files to drive improvements to product safety and customer experience.
Responsibilities include:
- Support medical incident investigations by ensuring Complaints team members are requesting pertinent clinical information from healthcare professionals to determine cause.
- Review clinical notes and develop root cause conclusion statements for medical or surgical incidents to support timely Vigilance reporting and complaint closure.
- Escalate high severity events as required to ensure appropriate investigation and actions are undertaken.
- Review complaints against product risk management documents for alignment and work with the risk management team to trigger updates when required.
- Review suitability and effectiveness of product risk mitigation measures with cross-functional teams to drive improvements to product safety and effectiveness.
- Support reviews of regulation changes pertaining to Vigilance reporting requirements to ensure appropriate procedure updates are implemented to maintain compliance.
- Review procedures and work instructions on adverse event reporting requirements to ensure compliance to regulations and ease of application.
- Identify and support implementation of improvements to the complaints handling process, reporting and other interfacing processes and procedures to improve effectiveness and maintain compliance.
What makes this opportunity unique?
A high impact role using medical expertise and working cross-functionally to conduct complaint investigations and feedback findings into the product risk management process to support improvement of Cochlear’s customers’ experience.
Key Requirements;
- Experience in surgery / operating room setting as a doctor or surgical support nurse, ideally in the area of otology or ENT will be advantage.
- Bachelor’s Degree, preferred Medical Science and Healthcare background.
- Minimum of 3 years’ work experience in the medical industry.
- Experience investigating adverse events due to surgical complications.
- Fluent in medical terminology.
- Understand the risk profile of different surgical procedures and medical conditions.
- Experience in reporting adverse events to regulatory bodies.
- Working knowledge of 21 CFR Part 820 and 803, and ISO 13485
- Experience in treating, or supporting the treatment of, patients in a hospital or clinic setting.
- Diagnosed causes through examination of patients and confidently interpret clinical notes.
- Highly developed analytical and problem-solving skills.
- Strong interpersonal skills with a demonstrated ability to engage with a range of key stakeholders, both internal and external.
- Excellent written and verbal English communication, organizational, presentation, collaboration and follow-up skills is a MUST for this role.
Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
#CochlearCareers
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