Job title:
Medical Devices – Product Surveillance Specialist
Company:
Guerbet
Job description
Medical Devices – Product Surveillance Specialist M/FLocation : Villepinte (93)Responsibilities:
- Capture, review and analyze product complaints.
- Follow-up on customer usage reports and field service reports as necessary.
- Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation, and reporting of product usage experiences. This includes determining if complaints qualify as Medical Device Reports per Global Health Authorities regulations and guidance or if complaints potentially qualify as Vigilance reports per Global Health Authorities regulations. It also includes evaluation of complaints for possible Adverse Events which are then forwarded to pharmacovigilance for review.
- Collaborate with field service and manufacturing site personnel.
- Review completed investigations for complaints and vigilance reports.
- Collaborate with colleagues on reporting to regulatory bodies for imaging drug products and devices.
- Conduct trend analyses in order to provide an alert to changing safety profiles on regular and adhoc basis.
- Prepare and deliver accurate reports of continuing product performance for use within and outside of the department.
- Identify potential product performance issues and alert appropriate management personnel when needed.
- Work in conjunction and effectively communicate 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.
- Expanding technical and clinical knowledge of current product portfolio and new products.
- Provide support during audits and regulatory inspections.
- Participate in networking events with internal customers.
- Performs other duties as required or assigned.
Desired Profile:
- 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.
Reason to join US:Much more than a Competitive salary,
We offer continued personal development. When you join Guerbet, you :
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
- Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717
Expected salary
Location
Villepinte, Seine-St-Denis
Job date
Thu, 12 Sep 2024 06:02:35 GMT
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