🧾 Job Title: Regulatory Affairs Specialist – Medical Devices (2–5 Years Experience) Location: Navi Mumbai Reports to: Regulatory Affairs AGM Job Summary: We are looking for a Regulatory Affairs Specialist with 2 to 5 years of hands-on experience in the medical device industry , specializing in regulatory submissions for the US (FDA) and European Union (EU MDR 2017/745) . You will be responsible for preparing and maintaining high-quality regulatory submissions and technical documentation, ensuring compliance across product lifecycles and markets. Key Responsibilities: US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications PMA supplements or De Novo requests (if applicable) Support establishment registration and device listing Ensure compliance with 21 CFR Part 820 (QSR) and UDI requirements Collaborate with the Quality team during FDA inspections EU Regulatory Support: Compile and maintain Technical Documentation in accordance with EU MDR 2017/745 Prepare and manage: CE marking submissions SSCPs (Summary of Safety and Clinical Performance) Declaration of Conformity Coordinate with Notified Bodies and participate in audits Assist in Post-Market Surveillance (PMS) , Vigilance reporting , and Periodic Safety Update Reports (PSUR) Cross-Functional & Strategic Support: Act as a Regulatory Affairs representative in Product Development Teams (PDT) Review and approve labeling, IFUs, promotional material, and packaging for regulatory compliance Participate in Change Control and assess regulatory impact globally Monitor evolving regulations (e.g., MDCG guidance, FDA guidance) and communicate impact to internal stakeholders Qualifications: Bachelor's degree in Pharmacy , or a related discipline 2–4 years of experience in Regulatory Affairs in the medical device industry Experience with Class I or II medical devices under FDA and EU MDR Solid understanding of: 21 CFR 807, 812, 814, 820 EU MDR Annexes II & III , and ISO 13485:2016 Key Skills & Tools: Regulatory submissions (510(k), CE Marking, EU MDR documentation) Use of tools like eSTAR (FDA) , EUDAMED , or Regulatory Information Management (RIM) systems Strong technical writing and documentation skills Experience working with Notified Bodies and/or FDA reviewers Excellent organizational, problem-solving, and communication skills Ability to work cross-functionally in a matrix environment What We Offer: Exposure to global regulatory strategies and cross-border product registrations Opportunity to work on innovative Class I/II medical technologies Career growth path in Regulatory Affairs & Quality Management Collaborative, fast-paced work environment Kindly share your resume at amits@firsttimeusgenerics.com and/or sujitkumarfirke@firsttimeusgenerics.com