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Global Regulatory Affairs Expert
2 months ago
INSPIRE MEDICAL SYSTEMS
Inspire Medical Systems stands at the forefront of the medical industry, committed to improving the lives of individuals affected by Obstructive Sleep Apnea (OSA). Our groundbreaking FDA-approved device is designed to reduce the severity of OSA for those who find limited success with traditional CPAP therapy. We prioritize patient outcomes and are dedicated to providing innovative solutions for those seeking alternatives in sleep apnea treatment.
Our Culture
At Inspire, we value diversity and believe that unique perspectives and experiences enrich our community. We foster an environment that encourages continuous learning and collaboration, creating a supportive network among our team members. Our employee-centric policies include flexible work arrangements, competitive benefits, 401k matching, an Employee Stock Purchase Plan (ESPP), generous time off, and opportunities for professional development. If you are passionate about making a meaningful impact and working with advanced technology, we invite you to explore a career with us.
Position Summary
The International Regulatory Affairs Specialist is responsible for providing regulatory support for implantable neurostimulation therapies aimed at treating obstructive sleep apnea. This role involves overseeing assessments of manufacturing and design changes, as well as compliance operations across the Asia Pacific region. The specialist will work closely with local partners to achieve regulatory goals efficiently.
Key Responsibilities
- Conduct regulatory assessments for design and manufacturing changes, including engineering change orders and supplier modifications.
- Collaborate with technical experts in product development, quality assurance, and clinical affairs to address inquiries from regulatory agencies.
- Document field reports and complaints for regulatory compliance.
- Coordinate with international regulatory teams to enhance submission quality and respond to inquiries from foreign regulatory bodies.
- Review product labeling and promotional materials to ensure compliance with regulatory requirements.
Minimum Qualifications
- Bachelor's degree in a relevant field.
- Experience in international environments, adapting to various business cultures.
- Strong written and verbal communication skills.
Preferred Qualifications
- Previous experience in the medical device industry, particularly in regulatory affairs, quality assurance, or engineering.
- Educational background in technical or scientific disciplines.
- Experience in handling complaints or evaluating post-market changes.
- Proficiency in a foreign language, preferably in Asian languages.
