Global Medical Device Vigilance Specialist

WS Audiology Group; Polska; Hybrid; PLN 120,000 - 170,000; Full time

Job summary

WS Audiology Group in Poland seeks a Vigilance Specialist to join our global Quality & Regulatory Affairs team. You will assess post-market information, prepare reports, and support investigations to ensure patient safety and regulatory compliance.

The role collaborates with Quality, Regulatory Affairs, R&D, Manufacturing, and Customer Support to drive continuous improvement and risk management, including CAPA input and PMS reporting. Fluent English is required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs or a related field.
• Experience in medical device vigilance, regulatory reporting, post-market surveillance or post-market quality.
• Experience assessing adverse events and determining regulatory reportability.
• Experience preparing and managing global vigilance submissions.
• Good knowledge of applicable medical device regulations and standards, including: 21 CFR 803, 21 CFR 820, EU MDR Vigilance Requirements, ISO 13485, ISO 14971.

Responsibilities

• Assess adverse events and determine reportability under global regulations.
• Prepare, review and submit vigilance reports and regulatory submissions.
• Ensure timely and accurate reportable event submissions.
• Prepare clear, accurate regulatory narratives and supporting docs.
• Maintain vigilance records in inspection-ready state.
• Support communication with regulatory authorities and respond to questions.

Skills

Vigilance expertise

Regulatory reporting

Post-market surveillance

Medical device regulations

Regulatory writing

Cross-functional collaboration

Data analysis

Attention to detail

Fluent English

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs or a related field

Job description

WS Audiology Group in Poland seeks a Vigilance Specialist to join our global Quality & Regulatory Affairs team. You will assess post-market information, prepare reports, and support investigations to ensure patient safety and regulatory compliance.

The role collaborates with Quality, Regulatory Affairs, R&D, Manufacturing, and Customer Support to drive continuous improvement and risk management, including CAPA input and PMS reporting. Fluent English is required.