Vigilance Specialist (m/f)

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

At WSA, patient safety and product quality are at the heart of what we do. As part of our global Quality & Regulatory Affairs organization, the Vigilance Specialist plays an important role in ensuring that post-market information is assessed accurately, regulatory requirements are met, and potential product safety risks are identified and addressed.

What you will do

The role combines medical device vigilance, regulatory reporting, safety assessment and cross-functional collaboration. You will work closely with Quality, Regulatory Affairs, R&D, Manufacturing, Supply Chain and Customer Support to evaluate post-market information, support investigations and contribute to product safety and continuous improvement.

Vigilance & Regulatory Reporting

• Assess adverse events and product performance issues and determine whether they are reportable under applicable global regulations.

• Prepare, review and submit vigilance reports, including FDA MDRs, EU MIRs and other country-specific regulatory submissions.

• Ensure reportable events are assessed and submitted accurately and within the required regulatory timelines.

• Prepare clear, accurate and scientifically sound regulatory narratives and supporting documentation.

• Maintain vigilance records and documentation in an inspection-ready state.

• Support communication with regulatory authorities and follow up on questions related to vigilance submissions.

Safety Assessment & Risk Evaluation

• Conduct Health Hazard Evaluations (HHEs) and support product safety assessments for potential market actions.

• Review complaint, investigation and post-market data to understand potential patient safety and regulatory implications.

• Identify and elevate significant safety concerns and emerging risks.

• Support alignment between vigilance activities, risk management documentation and product risk-benefit assessments.

Investigation & Cross-Functional Collaboration

• Work closely with Business Quality, Regulatory Affairs, R&D, Manufacturing, Supply Chain and Customer Support on product investigations.

• Review investigation outcomes and ensure they adequately address reportability and patient safety considerations.

• Provide vigilance input to CAPA activities, risk assessments and product quality improvements.

• Support field actions, recalls and other post-market activities when required.

Data, Trending & Signal Detection

• Analyze post-market data to identify trends, emerging risks and potential safety signals.

• Participate in periodic safety reviews and cross-functional data review meetings.

• Provide data and insights for Management Reviews, PMS Reports, PSURs, PMCF activities and other post-market deliverables.

• Support continuous improvement by analyzing vigilance and post-market quality metrics.

Compliance & Continuous Improvement

• Ensure vigilance activities comply with applicable medical device regulations, standards and internal procedures.

• Support internal audits, Notified Body audits and regulatory inspections as a vigilance subject matter expert.

• Ensure vigilance evaluations, records and submissions are complete, accurate and audit-ready.

• Contribute to remediation and continuous improvement activities following audits, inspections or quality initiatives.

What you bring

Experience

• 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 – Medical Device Reporting, 21 CFR 820, EU MDR Vigilance Requirements, ISO 13485, ISO 14971

• Ability to interpret regulatory requirements and apply them to complex product safety situations.

• Experience with Software as a Medical Device (SaMD), electronic medical devices or Class IIa medical devices is an advantage.

• Experience with regulatory inspections, Notified Body audits or electronic Quality Management Systems such as TrackWise, Veeva or IQVIA is an advantage.

Personal competencies

• Strong analytical and problem-solving skills, with excellent attention to detail.

• Sound judgment and confidence in making decisions based on regulatory and safety requirements.

• Strong technical and regulatory writing skills.

• Able to work effectively with different functions and stakeholders.

• Well organized and able to manage multiple priorities and deadlines.

• Proactive approach and willingness to identify and address potential issues.

• Continuous improvement mindset.

• Strong commitment to patient safety and product quality.

• Fluent English, both written and spoken.

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status, we firmly believe that our work is at its best when everyone feels free to be their most authentic self.