Regulatory Affairs Associate

Role & responsibilities

• Author review and approved relevant procedures as applicable as per the required QMS system.
• Maintain the Quality Management System on site, define quality procedures in conjunction with operating staff.
• Regulatory experience in preparing technical files and supporting projects for CE Certifications.
• In house EUMDR experience providing support for the clients and leading client projects.
• Good knowledge of Medical device labelling and understanding of review & approvals for medical device labels.
• Very good knowledge of ISO standards / Industry compliance regulatory standards like ISO 13485/ 10993/ 14971.
• Understanding of CER/CEP and provide support to clinical team.
• Support & resolve regulatory document related queries from manufacturers and provide solutions.
• Ensure client projects are performed and documentation prepared, reviewed and approved in line with relevant legislation requirements and guidance, meeting any specific requests or methodologies following the system and procedures in place.
• Manage and build on client relationships ensuring feedback sessions are completed on a regular basis.
• Set, communicate and train regulatory standards in the company in support of the Regulatory Compliance.

Preferred candidate profile

• Master's / Post Graduate degree in Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology).
• 2+years experience within a Medical Device/ IVD regulated industry with experience in Regulatory Affairs.
• Experience with EU and other international medical device regulations and submissions. 
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Demonstrated experience reviewing and analysing documentation.
• Must be able to productively generate quality documentation to meet Program timelines.
• Possess good written and oral communication skills. 
• Strong organisational and follow-up skills, attention to detail, excellent interpersonal skills to deal with multiple business functions and personnel across the organisation, ability to identify obstacles and offer solutions. 

Perks and benefits

• Medical Insurance
• Gratuity
• Bonus
• Remote Working