What are the responsibilities and job description for the Regulatory Affairs Specialist position at Health Marketing?
Role: Regulatory Affairs Manager for medical device products.
Responsibilities Include
Responsibilities Include
- Managing submissions, registrations, and listings for medical devices.
- Conducting complaint investigations, product reviews, and post-market surveillance.
- Performing audits and reviewing technical files to ensure compliance.
- Supporting staff training on regulatory requirements.
- Coordinating with regulatory agencies and advising stakeholders on compliance risks.
- Ensuring adherence to domestic and international regulations and quality system standards.
- Knowledge of medical device regulations and quality systems.
- Strong understanding of regulatory submission processes and compliance management.
- Excellent communication and coordination abilities.
- Attention to detail in audits, reviews, and investigations.