Medical Devices Product Surveillance Specialist
il y a 3 semaines
About the Role:
We are seeking a highly skilled Product Surveillance Specialist to join our team at Guerbet. As a Product Surveillance Specialist, you will be responsible for capturing, reviewing, and analyzing product complaints, as well as following up on customer usage reports and field service reports as necessary.
Key Responsibilities:
- Capture, review, and analyze product complaints to identify potential product performance issues.
- Follow up on customer usage reports and field service reports to ensure compliance with global product quality related guidelines, standards, and regulations.
- Collaborate with field service and manufacturing site personnel to resolve product complaints and improve product performance.
- Review completed investigations for complaints and vigilance reports to ensure accuracy and completeness.
- Collaborate with colleagues on reporting to regulatory bodies for imaging drug products and devices.
- Conduct trend analyses to identify changing safety profiles and provide alerts to management personnel.
- Prepare and deliver accurate reports of continuing product performance for use within and outside of the department.
- Identify potential product performance issues and alert management personnel when necessary.
- Work effectively with various departments, including Legal Affairs, Regulatory Affairs, R&D, Manufacturing, Marketing, Medical Affairs, Sales, and Customer Service.
- Provide product performance expertise on cross-functional project teams as necessary.
- Expand technical and clinical knowledge of current product portfolio and new products.
- Support during audits and regulatory inspections.
- Participate in networking events with internal customers.
Requirements:
- Previous Regulatory Affairs, Quality Assurance experience in the Pharmaceutical and/or Medical Device industry.
- A minimum of 3 years practical experience in the pharmaceutical environment, with an international exposure.
- Experience interacting with regulatory agencies such as the FDA.
- Quality Management Systems (QMS) experience preferred.
- Writing and verbal skills necessary to effectively communicate technical information to others.
- Comfortable and capable of using software programs (Word, Excel, PowerPoint) and a willingness to expand and increase these competencies.
- Involvement with field actions for drugs and/or medical devices preferred.
- BA/BS Degree in life science, engineering, business, or equivalent.
Why Join Guerbet:
Guerbet is a global leader in diagnostic and interventional imaging, with a commitment to innovation, cooperation, care, and achievement. As a Product Surveillance Specialist, you will be part of a diverse team of 2820 collaborators who are dedicated to improving the quality of patient's life worldwide.
We value diversity of talents and believe that no individual should be discriminated against because of their differences. Guerbet is an Equal Opportunity Employer and is committed to diversity, equity, and inclusion.
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