Average salary: Rs3,249,999 /yearly
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- ...about 25% of the world's population. Their 1st product, KIMIA Recover, a continuous monitoring device for the knee joint, has obtained FDA Approval, CE marking and HSA approval, and booked revenues from large implant companies and hospitals. It has recently won the Johnson...SuggestedImmediate start
- ..., or a related function within the Medical Device or IVD industry. ~ Basic understanding of regulatory frameworks such as MDR, IVDR, FDA regulations, and international product registration requirements. ~ Experience supporting regulatory submissions and maintaining regulatory...SuggestedHybrid workImmediate start
- ...Support in evaluating adherence to healthcare laws and regulations such as Anti-Kickback Statute, False Claims Act, PhRMA Code and FDA promotional compliance standards. Identify audit observations, root causes, and business impacts; quantify where applicable. Draft...Suggested
- ...May Be for You If You Have: Strong knowledge of ICH E2A, E2B, and E2D guidelines and global pharmacovigilance regulations including FDA, EMA, and Health Canada requirements Hands-on experience in ICSR intake, case processing, and expedited reporting workflows Proficiency...SuggestedWork at office
- ...provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are you ready? Our approach is simple; we put the client’s interests first,...SuggestedFull timeWorldwide
- ...Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR...Suggested
- ...can build relationships and drive outcomes independently but in conjunction with the wider team Understanding of GxP, 21 CFR Part 11 and FDA AI/ML guidance Familiarity with IT functions within the pharmaceutical industry, pharma platforms and clinical workflows Experience...Suggested
- ...rigorous code reviews and provide constructive technical feedback to ensure adherence to medical device software standards (IEC 62304, FDA regulations) ~ Optimize application performance by identifying and resolving bottlenecks in resource-constrained embedded Linux environments...SuggestedFull timeHybrid workWork at office3 days week
- ...technical documentation, validation documents, database specifications, and programming guidelines.- Ensure compliance with CDISC, GCP, FDA, ICH, and 21 CFR Part 11 regulations.- Participate in database review meetings and provide technical recommendations for study...Suggested
- ...support, NLP pipelines, or predictive analytics products.- Exposure to regulatory compliance frameworks relevant to healthcare software (FDA SaMD, SOC 2 and ISO 27001).- An engineering background (BS/MS in CS, CE, or a related field is preferred but not required with...SuggestedLong term contractFull time
- ...Understanding of ISO 13485 and exposure to ISO 14971 preferred. ~ Bachelor’s degree in Biomedical, Life Sciences, Pharmacy, or related field. ~ Strong analytical, documentation, and communication skills. ~ Exposure to US FDA or global registrations is an advantage....Suggested
- ...systems (such as SAP and TrackWise) ensuring data integrity and system performance. • Ensure compliance with GxP standards (GMP, GLP, FDA, 21 CFR Part 11) and lead Computer System Validation (CSV) activities. • Act as the primary liaison between business stakeholders, IT...SuggestedFull time
- ...clinical-stage to commercial-stage biotechnology organization. ~Strong knowledge of healthcare compliance laws and regulations, including FDA promotional requirements, Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, PhRMA Code, HIPAA, and other applicable...SuggestedHybrid workWork at officeRemote job
- ...operations. - Ensure compliance with statutory, safety, and company regulations. - Coordinate with government authorities, EIA, MPEDA, US FDA, insurance companies, and audit agencies. - Handle inspections, certifications, documentation, and export compliance. - Support...SuggestedFull time
- ...Experience programming languages, such as PL/SQL, JAVA SCRIPT. • Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance. • Understanding of Clinical trial process and Data management activities • Proficient...SuggestedFull timeWork at office
- ...or equivalent tool-serving frameworks Familiarity with GxP/regulated software environments, GAMP5 validation, CSV/CSA approaches, or FDA software guidance Prior work on document processing pipelines including OCR, PDF extraction, email parsing, or structured data...
- ...cross-functional stakeholders.- Prepare technical design documents and support system validation activities.- Ensure compliance with GxP, FDA, EMA, and pharmacovigilance regulations.Required Skills :- Strong experience with Oracle Argus Safety Development.- Hands-on experience...Full time
- ...manufacturing teams across development stages. # Ensure compliance with industry safety and regulatory standards (UL, CSA, FM, ISO, IEC, NEC, FDA). # Communicate design decisions, risks, and results to global stakeholders. For This Role, You Will Need: Bachelor's/Master'...Full time
- ...of Good Documentation Practices (GDP), medical device quality processes, and external audits.- Exposure to Design History Files (DHF), FDA-regulated products, or Software as a Medical Device (SaMD).- PMP certification or familiarity with PMBOK methodologies.- Technical exposure...
- ...Monitor batch manufacturing records (BMR) and ensure timely documentation. Compliance & Quality Maintain strict compliance with cGMP, FDA, MHRA, and other regulatory requirements. Coordinate with QA/QC to ensure product quality and resolve deviations. Drive...Full timeShift work
- ...sterilization validation, environmental monitoring, and contamination control. Support regulatory inspections and ensure compliance with US FDA, EU GMP, WHO, MHRA, and PIC/S requirements. Deliver training on Internal Audits, DI, Sterility Assurance, and cGMP while promoting a...Full time
- ...design, business processes redesign and software implementation in a drug development lab / commercialization environment- Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas- Strong analytic/critical-...Full timeFor contractors
Rs 2 - 2.4 lakhs p.a.
...early applicant About the job Key responsibilities: 1. Support the preparation, formatting, quality control, and assembly of U.S. FDA regulatory submissions and technical documentation. 2. Review dense scientific and regulatory documents in detail to identify errors...Hybrid workImmediate startShift work- ...strategy discussions. Healthcare or Medical Device domain experience. Knowledge of Medical Device Software Development Lifecycle, FDA regulations, and IEC 62304. Experience with Python-based automation frameworks. Exposure to CI/CD tools and ALM platforms such as...Full time
- ...Skills & Attributes Exposure to business development activities and client engagement strategies Good knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) Ability to create innovative insights and contribute to thought leadership Experience in process...Full timeWorldwide
- ...Connected Medical Devices (IoMT).5. SaMD (Software as a Medical Device).6. Wearables and Digital Health Solutions.- Ensure compliance with FDA, MDR, ISO 13485, IEC 62304, and other healthcare regulations.Customer & Stakeholder Management : - Act as the primary liaison for...
- ...programs. This individual will serve as an independent contributor responsible for developing high-quality regulatory documents supporting FDA interactions and clinical development activities. The ideal candidate brings extensive medical writing experience in Autoimmune...Full timeRemote job
- ...and commitment to compliance. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what...Contract work
- ...Instrumentation, or a related technical field; advanced degree is a plus. Prior experience in scientific, industrial, or instrument-control software environments is highly desirable. Familiarity with regulatory requirements such as FDA or ISO standards / ISTQB certification...Remote jobFull timeWork at officeWorking Monday to Friday
- ...regulatory audits. Collaborate with cross-functional teams to support document management activities. Ensure compliance with GDP, GMP, FDA regulations, ISO standards, and company policies. Lead document control investigations, Change Controls, CAPAs, and continuous...Remote jobFull timeWork at officeWorking Monday to Friday