You will ensure medical devices meet all regulatory requirements and obtain necessary market approvals. This role involves strategic planning and interaction with regulatory bodies, ensuring compliance and facilitating product launches.
Responsibilities:
- Prepare and manage regulatory submissions and documentation.
- Monitor regulatory developments and advise on compliance strategies.
- Engage with regulatory authorities to negotiate and secure product approvals.
- Support product teams with regulatory guidance throughout the product lifecycle.
Skills and Qualifications:
- Bachelors in Life Sciences, Biomedical Engineering, or related.
- 4+ years of regulatory affairs experience in the healthcare industry.
- Comprehensive knowledge of global regulatory standards and processes.
- Strong organizational, communication, and analytical skills.