Regulatory Affairs Specialist

10 hours ago

Mumbai, India Illusion Dental Laboratory Full time

Job Description Job Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to Saturday Job Summary: We are seeking a motivated and detail-oriented Regulatory Affairs Executive to join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions. Key Responsibilities: Conduct gap analysis of existing regulatory and technical documentation. Prepare and maintain regulatory submissions including: Device Master Files Risk Management Files Design History Files Clinical Evaluation Reports Usability Reports Draft and update product labeling content such as Instructions for Use (IFUs) , implant cards , and declarations to meet global compliance requirements. Support regulatory submissions for India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets. Coordinate with cross-functional teams including Purchase, Accounts, Legal, Marketing , and R&D to gather documentation and resolve queries. Assist in preparing and submitting responses for audit-related queries and regulatory inspections. Contribute to regulatory strategy for new product developments and modifications. Stay updated with changes in regulatory requirements and industry trends through self-learning and structured training. Educational Qualifications: Bachelor’s or Master’s degree in Pharmaceutical Sciences , Engineering , Biotechnology , Microbiology , or a related life science field. Specialization in Regulatory Affairs or Quality Assurance preferred. Experience: 1 to 4 years of industry experience in a Regulatory Affairs role, preferably in medical devices, pharmaceuticals, or life sciences. Hands-on experience with global and domestic regulatory submissions. Exposure to documentation systems and regulatory portals (CDSCO/SUGAM/NSWS) is essential. Experience or knowledge of software regulations is an added advantage. Key Skills and Competencies: Strong knowledge of: Regulatory frameworks including ISO 13485, EU MDR, and 21 CFR Part 820 Risk management , design controls , and post-market surveillance Excellent documentation, analytical , and technical writing skills Proficient in Microsoft Office Suite and digital documentation platforms Strong interpersonal skills to collaborate with internal departments and external bodies Soft Skills: Go-getter attitude with the willingness to lead and take initiative High English proficiency – both verbal and written Strong organizational and time management skills Ability to work independently and as part of a cross-functional team. Fast learner with a proactive mindset for continuous development. Monday to Saturday working Company Website:

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