Global Complaints, Vigilance and PMS Specialist

• Ensure that complaints are properly addressed, investigated, and closed in compliance with procedures and regulations, including EU MDR 2017/745 and MDSAP
• Lead and assist in the assessment of each complaint case for reportability per regulatory requirements; prepare and submit reportable incidents to the appropriate authorities, meeting deadlines set by regulations
• Collaborate closely with interdisciplinary teams such as Quality Control (QC), R&D, and Medical Advisors to coordinate investigations and complete complaint files
• Engage with customers and end-users to collect necessary information for complaint investigations
• Develop and issue Post-Market Surveillance (PMS) plans and reports according to device classification requirements
• Create reports based on complaints data to ensure timely and comprehensive analysis
• Organize and maintain complaint and vigilance files, ensuring accurate and up-to-date documentation
• Independently manage and organize your workday, allowing flexibility to address varying priorities as they arise

• Experience in regulatory roles within the medical device industry, particularly in FDA- or ISO-regulated international environments, with a focus on complaint management specific to medical devices and regulatory reporting
• Experience in Quality and/or Regulatory Affairs with knowledge of requirements for regulated products
• Fluent in English; knowledge of other languages (French) would be an advantage
• Strong cross functional communication and business writing skills
• Familiarity with PMS (Post-Market Surveillance) processes is a plus
• Candidates must possess a valid work permit for Poland; Polish language skills are welcome but not required.

• Flexible working hours and remote work opportunities to promote a healthy work-life balance
• Private healthcare coverage to ensure your well-being and peace of mind
• Opportunities for workcations, allowing you to work from different locations while staying connected with your team
• Sports card (Multisport) to support your health and fitness goals
• A chance to contribute to our rapidly growing center of excellence in Poland, while benefiting from working for an international company with headquarters in the US

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com