SINNOV8 Technologies is hiring for the role of Regulatory Affairs (RA) Specialist. If you have 1 to 5 years of experience and expertise in regulatory compliance, this could be the perfect opportunity for you to grow your career.
About SINNOV8 Technologies
SINNOV8 Technologies is a leader in providing regulatory consulting and solutions for the medical devices and healthcare sectors. We specialize in helping businesses meet global regulatory requirements, including ISO standards and FDA approvals. With a focus on innovation and compliance, SINNOV8 ensures that medical devices align with the latest global standards.
Key Responsibilities
- Ensure products meet ISO 13485 and ISO 14971 standards for quality and risk management.
- Assist in CDSCO, EU MDR, and EU MDD submissions and ensure product compliance with regional regulatory frameworks.
- Manage US FDA and IVDR regulatory documentation and approvals.
- Work closely with cross-functional teams to maintain compliance throughout the product lifecycle.
- Monitor and interpret new regulatory changes and ensure timely updates to internal policies.
Qualifications and Experience
- Experience: 1-5 years in Regulatory Affairs.
- Knowledge: Familiarity with ISO 13485, ISO 14971, CDSCO, EU MDR, EU MDD, US FDA, and IVDR regulations.
- Location: Remote position, offering flexibility and work-from-home opportunities.
Key Skills
- Strong understanding of global regulatory standards and requirements.
- Excellent organizational and analytical skills to handle documentation.
- Ability to work independently and collaborate with cross-functional teams.
- Strong written and verbal communication skills.
How to Apply
If you meet the qualifications and are interested in this exciting opportunity, send your CV to:
📧 kanika.sharma@sinnov8.com
