Product Surveillance Specialist

Essential Functions

• 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 or 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 evaluations 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 porfolio and new products.
• Provide support during audits and regulatory inspections.
• Participate in networking events with internal customers.

Candidate Profile

• Previous Regulatory Affairs, Quality Assurance experience in the Pharmaceutical and/or Medical Device industry is strongly preferred.
• A minimum of 2 years practical experience in a relevant environment is required.
• 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.

Education

BA/BS Degree in life science, engineering, business or equivalent.