Senior Regulatory Affairs Specialist

Job summary

The Senior Regulatory Affairs Specialist will play a key role in supporting strategic regulatory initiatives and ensuring compliance for medical devices aimed at treating hearing loss in global markets. This position is part of a dedicated Regulatory Affairs team focused on quality and collaboration.

Qualifications

• Proven experience in Regulatory Affairs within a global medical device context, preferably with hearing healthcare products or similar regulated technologies.
• Strong understanding of EU MDR and MDSAP regulations, including compliance expectations and regulatory pathways.
• Ability to blend strategic regulatory work with daily execution and delivery.
• Excellent interpersonal skills to build effective relationships with diverse stakeholders.
• Strong communication skills to convey complex regulatory topics clearly and appropriately.

Responsibilities

• Support strategic initiatives within Regulatory Affairs.
• Ensure regulatory compliance for medical devices in global markets, focusing on EU and MDSAP.
• Engage in regulatory activities throughout the product lifecycle, including assessments, submissions, registrations, and change management.
• Collaborate with cross-functional teams in R&D, Quality, and Commercial areas.
• Act as a regulatory partner by simplifying complex regulatory requirements into actionable guidance.
• Facilitate internal alignment and decision-making through effective communication and stakeholder engagement.

Education

• Relevant degree in a scientific or regulatory field is preferred.

Tools

• Familiarity with regulatory submission tools and compliance management systems is advantageous.