Global Complaints, Vigilance and Post-Market Specialist

Purpose

As the Global Complaints, Vigilance, and Post-Market Specialist, you will oversee the management of customer complaints for surgical ophthalmic devices across multiple international markets. In this global role, you will coordinate investigations, ensure compliance with regulatory requirements, and maintain Post-Market Surveillance (PMS) files. Your expertise in PMS and regulatory reporting will be essential in supporting our quality management processes and ensuring timely incident reporting.

US Time Zones: Please note you must be available to work during US business hours to ensure effective communication and collaboration with our teams and stakeholders in the United States.

Key Responsibilities

• Complaint Management : Ensure that complaints are properly addressed, investigated, and closed in compliance with procedures and regulations, including EU MDR 2017/745 and MDSAP;
• Complaint Investigation Coordination : Oversee the completeness of complaint investigations with interdisciplinary teams such as QC, R&D, and Medical Advisors. Ensure that complaint files are complete and consistent. Follow up with customers if additional information is needed;
• Customer Communication : Communicate with customers and end-users to gather any additional information required for complaint investigations;
• Regulatory Assessment : Lead and assist in assessing each complaint case to determine if it needs to be reported under regulatory requirements like EU MDR 2017/745 and MDSAP;
• Vigilance Coordination : Liaise with the Vigilance Team to report any potential incidents identified during PMS activities;
• Data Analysis Reporting : Create reports based on complaints data to ensure timely and comprehensive analysis;
• Incident Reporting : Prepare and submit reports of incidents to the appropriate authorities, adhering to the deadlines specified by EU MDR 2017/745 and MDSAP;
• File Management : Manage and maintain complaint case and vigilance files to ensure accurate and up-to-date records;
• PMS Planning : Develop and issue Post-Market Surveillance (PMS) plans according to device classification timelines;
• Regulatory Reporting : Produce and share required reports, such as PMS reports, SSCPs, and PSURs, with relevant stakeholders.
  
  

Qualification

• University degree in Life Sciences or a related field (Chemistry, Pharmacy, Biology, Biochemistry)
• Minimum 3 years of regulatory experience in the medical device industry, specifically within FDA or ISO-regulated environments
• Fluent in English; knowledge of other languages is an advantage
• Ability to readily adjust to change in a fast-paced, international, and diverse environment and multitask
• Proven experience in Quality and/or Regulatory Affairs with knowledge of requirements for regulated products
• Strong project management skills with experience working in a complex, global cross-functional organization
• Strong communication and business writing skills
• Must be available to work during US business hours
  
  

What You’ll Get in Return:

• 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
  
  

Company

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