Regulatory Affairs Specialist SINNOV8 Technologies
Company: SINNOV8 Technologies
Location: Work from Home (Remote)
Experience: 1 to 5 years
Education: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences, Biomedical
Application: Email
About SINNOV8 Technologies
SINNOV8 Technologies is a leading provider of regulatory consulting and solutions for the medical devices and healthcare industries. We specialize in assisting businesses to meet global regulatory requirements, including ISO standards, FDA approvals, and more. Join our innovative team to ensure that medical devices adhere to the latest global standards. Regulatory Affairs Specialist SINNOV8 Technologies
Position: Regulatory Affairs (RA) Specialist
Experience: 1 to 5 years in Regulatory Affairs
Location: Work-from-home, offering flexibility
Skills: Knowledge of ISO 13485, ISO 14971, CDSCO, EU MDR, EU MDD, US FDA, and IVDR regulations
Regulatory Affairs Specialist SINNOV8 Technologies
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 to ensure product compliance with regional regulatory frameworks
- Manage US FDA and IVDR regulatory documentation and approvals
- Collaborate with cross-functional teams to maintain compliance throughout the product lifecycle
- Monitor and interpret regulatory changes to update internal policies accordingly
Regulatory Affairs Specialist SINNOV8 Technologies
Key Skills
- Strong understanding of global regulatory standards and requirements
- Excellent organizational and analytical skills to handle documentation
- Ability to work independently and with cross-functional teams
- Strong written and verbal communication skills
Regulatory Affairs Specialist SINNOV8 Technologies
How to Apply
Interested candidates can send their CV to:
📧 kanika.sharma@sinnov8.com
This is a great opportunity to contribute to regulatory innovation while working remotely with a leading team in the healthcare sector!
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