Regulatory submissions to health authorities worldwide;<br /> Support submission planning including applying intelligence and develop regulatory<br />strategy<br /> Support preparation and maintenance of regulatory files<br /> Support submission of regulatory files, response to questions from health authorities and<br />maintenance of marketing authorisations globally, e.g.:<br /> MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, post<br />approval changes and commitments<br /> Support interactions with affiliates<br /> Regulatory interactions with health authorities<br /> Support the planning and conduct of regulatory authority interactions. Provide input to the<br />preparation of meeting requests, meeting packages, rehearsal and taking minutes of formal<br />meetings<br /> Provide input to affiliates for preparation of health authority interaction<br /> Monitor and renewals handling.<h3>experience</h3>7

<p>Job Title: Regulatory Affairs (Medical Devices)</p><p>Job Description</p><p>The RA oversees market access and regulatory strategy, holding authority for global submissions, planning regulatory pathways, managing lifecycle approvals, and engaging with regulatory authorities, with a focus on global regulatory strategy. </p><p>• Management of product registrations. </p><p>• Ownership of technical documentation. </p><p>• Preparedness for market access.</p><p> </p><p>Roles & Responsibility:</p><p>Regulatory Affairs – Technical submissions</p><ul><li>Define, develop and execute regulatory strategies to ensure fast Time to market all new/existing products.</li><li>Develop and maintain Technical Files/Design Dossier to comply with European MDD and maintain CE mark approval.</li><li>Develop and Maintain Technical Files/Design Dossier to comply with compliances and standards (CDSCO, 510K)</li><li>Overseeing and Planning, Compilation, review and submission of Documents as per Country Specific regulatory guideline in medical device manufacturing and coordinating with them for registration.</li><li>Prepare and maintain technical file and medical device master files as necessary to obtain and sustain product approval from applicable regulatory authorities</li><li>Accountable for the preparation and mantainence of technical documentation in accordance with EU MDR 2017 and other regulations such as USFDA, MDSAP, and CDSCO</li><li>Preparation of Post Marketing Surveillance Report, Post Market Clinical Follow Up (PMCF) Report, Periodic Safety Update Report (PSUR), Clinical Evaluation Report (CER), Clinical Investigation Report, Usability Engineering Report, Risk Analysis Report. </li><li>Facilitate the preparation and submission of documentation required for regulatory approval of manufacturing in India site.</li></ul><p> </p><p>Regulatory Strategy Ownership</p><ul><li>Define regulatory pathways for new markets and customers.</li><li>Regulatory risk assessment during customer onboarding</li><li>Support regulatory strategy for business expansion across organization </li></ul><p> </p><p>Lifecycle Management</p><ul><li>Renewal management of any audit (surveillance, regulatory certifications, External audits from notified bodies or any customer audits </li><li>The readiness and attentiveness regarding certifications and audits    </li><li>Act as RA representative and support resource on product development for new products approval/registration    </li><li>Notified Bodies and Competent Authorities</li><li>Observe global regulatory changes and execute required system updates</li><li>Act as Primary regulatory interface with Notified Bodies and Competent Authorities with </li></ul><p> </p><p>Technical Documentation Responsibilities </p><ul><li>Design History File (DHF).</li><li>Device Master Record (DMR) familiarity- recheck </li><li>CDSCO </li><li>TCF</li></ul><p> </p><p>2. Regulatory Affairs & Global Compliance</p><p>Manage registrations and lifecycle maintenance for:</p><ul><li>EU (CE Marking – MDR 2017/745)</li><li>ISO 13485: 2016</li><li>US FDA</li><li>UK MHRA</li><li>Health Canada</li><li>CDSCO (India)</li><li>MDSAP</li><li>510K</li></ul><p> </p><p>3. Audit & Compliance Management</p><ul><li>Regulatory audit readiness support</li><li>Regulatory inspection coordination Lead and manage external audits (ISO, regulatory authorities, customers)</li><li>Ensure timely closure of audit non-conformities (NCs)</li><li>Ensure full compliance with laws, regulations, SOPs, and industry guidelines</li></ul><ul><li>4. Cross-Functional Leadership & Coordination</li></ul><ul><li>Coordinate with Production, QC, R&D, Supply Chain, and Materials departments</li><li>Ensure manufacturing and QC processes comply with ISO and GMP</li><li>Oversee vendor qualification, approval, monitoring, and re-evaluation</li><li>Review and approve MIS reports and present quality/regulatory updates to leadership</li><li>Lead, mentor, and develop RA teams</li></ul><p> </p><p>5. Strategy, Business Growth & Governance</p><ul><li>Contribute to organizational strategy by aligning quality and regulatory goals</li><li>Support new business leads and market expansion from a /RA perspective</li><li>Assess regulatory and quality feasibility for new products and markets</li><li>Identify system improvements, risk mitigation opportunities, and productivity gains</li><li>Ensure organization-wide adherence to quality and regulatory governance frameworks</li><li>Global market access planning.</li><li>Regulatory feasibility assessment for customer proposals.</li><li>Support during pre-sales or business development discussions</li></ul><p> </p><p>Required Certifications</p><p>Mandatory / Highly Preferred</p><ul><li>ISO 13485:2016 Certified Lead </li><li>ISO 14971 Risk Management Training</li><li>EU MDR 2017/745 & 746 Training</li><li>CDSCO</li><li>US FDA 510k</li><li>Health Canada</li><li>UK MHRA</li><li>Global submission</li></ul><h3>experience</h3>15

<h4>Senior Regulatory Affairs Officer - Vapi, Gujarat</h4><h4>We are seeking a highly experienced and proactive Senior Regulatory Affairs Officer to join our team in Vapi, Gujarat. The ideal candidate will possess a strong background in regulatory affairs and a proven track record of success in preparing and submitting regulatory dossiers. This is a full-time, permanent position that offers a professional and formal work environment.</h4><h4>Job Title: Sr. Regulatory Affairs Officer – Finished Formulations Experience: 3 to 6 Years</h4><h4>Qualifications: B. Sc/ M. Sc- Organic Chem. Or B. Pharma / M. Pharma (Preferable) </h4><h4>Location: Vapi - Gujarat</h4><h4>Client is a leading specialist in Active Pharmaceutical Ingredients (APIs). We are a part of 50+ year-old group, currently exporting to 70 countries worldwide. The company has received global FDA accreditations from several countries, including the USFDA, EDQM, and the FDA of Russia, China, Japan, Mexico, Brazil, the UK, Australia, and Canada.</h4><h4>Job Responsibilities: </h4><h4>• Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. </h4><h4>• Handle full lifecycle of product registration including new submissions, renewals, and variations. </h4><h4>• Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc. </h4><h4>• Address Ministry of Health (MoH) queries and manage deficiency responses. </h4><h4>• Manage post-approval changes and variation submissions. </h4><h4>• Liaise with international regulatory agents and distributors for submission coordination. </h4><h4>• Artwork review and approval ensuring compliance with label regulations. </h4><h4>• Maintain up-to-date registration database and submission tracker. </h4><h4>• Prepare administrative documents: POAs, LOAs, legalization support, etc. </h4><h4>• Conduct compliance review for change controls, tech transfer documents, and CMO data. </h4><h4>• Support site registration and GMP audits when required. </h4><h4>• Review and finalize Quality Agreements with partners/clients. </h4><h4>• Handle pharmacovigilance documentation (via third-party support). </h4><h4> </h4><h4>Preferred Skills & Experience: </h4><h4>• Expertise in CIS, LATAM, EU, and African regulatory landscapes. </h4><h4>• Strong understanding of regulatory systems (e.g., UKMHRA, EMA, ANVISA CDSCO). </h4><h4>• Prior QC/analytical lab experience (esp. with HPLC) is a plus. </h4><h4>• Proficient in regulatory writing and dossier compilation independently. </h4><h4>• Strong coordination, analytical, and document management skills.</h4><h3>experience</h3>10