Job DescriptionJob Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to SaturdayJob Summary: We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto 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: Conductgap analysisof 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 asInstructions for Use (IFUs) ,implant cards , anddeclarationsto meet global compliance requirements. Supportregulatory submissionsfor India (via CDSCO/SUGAM/NSWS), US (FDA), EU (CE marking under MDR), and other applicable markets. Coordinate with cross-functional teams includingPurchase, Accounts, Legal, Marketing , andR&Dto gather documentation and resolve queries. Assist in preparing and submitting responses foraudit-related queriesand regulatory inspections. Contribute to regulatory strategy fornew product developmentsand 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 inPharmaceutical Sciences ,Engineering ,Biotechnology ,Microbiology , or a related life science field. Specialization inRegulatory AffairsorQuality Assurancepreferred.Experience: 1 to 4 yearsof 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 ofsoftware regulationsis an added advantage.Key Skills and Competencies: Strong knowledge of: Regulatory frameworksincluding ISO 13485, EU MDR, and 21 CFR Part 820 Risk management ,design controls , andpost-market surveillance Excellentdocumentation, analytical , andtechnical writing skills Proficient inMicrosoft Office Suiteand digital documentation platforms Strong interpersonal skills to collaborate with internal departments and external bodiesSoft Skills: Go-getter attitudewith the willingness to lead and take initiative HighEnglish proficiency– both verbal and written Strongorganizationalandtime managementskills Ability to work independently and as part of across-functional team. Fast learner with a proactive mindset for continuous development.Monday to Saturday working Company Website:
Job Title
Regulatory Affairs Specialist