Overseeing daily operations and work-in-progress (WIP) to ensure efficiency and adherence to quality standards and regulatory requirements.
Supervising a small team of analysts.
Supporting the professional development of individual contributors, helping them grow their skills and advance their careers.
Coordinating efforts with corporate partners and liaising with multiple geographical locations to align strategies and achieve common goals.
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
Establish and approve regulatory reportability decisions using event investigation and regulatory decision models.
Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
What We’re Looking For:
Bachelor or Licentiate’s degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Health Field.
At least 2-3 years of experience in similar positions
English Level desired: 80% - 90%.
Or an equivalent combination of education and experience.