Regulatory Product Surveillance Specialist

Job summary

The Regulatory Product Surveillance Specialist will support safety and clinical compliance for hearing solutions within the Corporate Quality department. This role involves post-market surveillance and vigilance activities to ensure medical device compliance.

Qualifications

• Healthcare professional qualification (medical doctor, clinical scientist, audiologist, or equivalent)
• Experience as a medical advisor, medical consultant, or similar role
• Strong knowledge of medical device regulations and applicable standards
• Ability to work independently and collaboratively in multidisciplinary teams
• Effective communication skills in English, both written and spoken

Responsibilities

• Manage safety-related customer feedback
• Conduct MDR/Vigilance reporting within the applicable regulatory framework
• Ensure regulatory compliance of post-market and vigilance procedures
• Perform clinical assessments to support product safety and regulatory decisions
• Provide medical input for complaint handling and risk management decisions
• Participate in audits and inspections, supporting ongoing audit readiness

Skills

• Strong analytical and problem-solving skills
• Ability to counsel and communicate clinical perspectives in an approachable manner

Education

• Relevant healthcare professional qualification

Tools

• Familiarity with regulatory compliance tools and medical device standards