397 Fda Jobs - Page 4

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a dif...

Provide expert consulting on designing, optimizing, and implementing quality management systems, ensuring alignment with industry best practices and regulations. Required Candidate profile 3+ years eClinical software exp; 8+ years in quality assurance/compliance/management within U.S. pharma; Deep knowledge of regulatory frameworks: FDA regulations, ICH GCP, 21 CFRPart 11.

IMEA (India, Middle East, Africa) India LIXIL INDIA PVT LTD Employee Assignment Fully remote possible Full Time 1 July 2025 Job Title: Salesforce Developer Company: LIXIL International Location: India Department: IT Digital Reports To: Leader, IT APAC Job Purpose: This position is a highly skilled Salesforce Application Support Specialist to provide support to LIXIL International across APAC countries This role is crucial for maintaining the stability and performance of LIXIL's Salesforce ecosystem, encompassing Sales Cloud, Service Cloud, Field Service, Marketing Cloud, and related integrations The ideal position will possess strong technical expertise, excellent problem-solving abilities, ...

Our Client is seeking an experienced Vice President Manufacturing to lead high-precision manufacturing operations, drive innovation in medical device production , and ensure world-class operational efficiency . The ideal candidate will possess deep expertise in micro-precision components, electronics manufacturing, and regulatory compliance for medical devices . Key Responsibilities: Vice President Manufacturing (Medical Devices & Micro Precision Components) Location: Chennai Oragadam Factory Experience Required: 18 to 25 years Industry: Medical Devices, Micro Precision Components, Electronics Manufacturing Manufacturing Leadership: Oversee end-to-end manufacturing operations for medical dev...

As the Automation Officer at our organization, you will play a crucial role in the design review, implementation, and maintenance of Process Automation Systems (PAS), PLC, and SCADA systems. This will involve working with key components such as Virtualization, Historian, DCS, RIO, OPC-UA, Profinet, and Serial communication. Your responsibilities will include coordinating with vendors to ensure the seamless integration of various equipment with the PAS. Effective communication and collaboration with stakeholders, both external and internal, will be essential to facilitate equipment integration while ensuring that all automation processes align with performance, quality, and regulatory standar...

Job Title: Senior R&D Engineer Medical Devices Location: Mumbai, IND Employment type: Part-time Position Summary: We are seeking an experienced R&D Engineer Trainer with 10+ years in the medical device industry to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launc...

Do you enjoy leading a team that provides a high-quality service for our customers Do you love collaborating with teams to solve complex problems Join our growing team We are leading the market in Wireline Services Our innovative solutions improve efficiency, production and maximize reservoir value Our Field Services team works onsite with our customers to support the on-site operations and planning of our industry-leading products, Partner with the best As the North Gulf Scheduling & Competency Specialist Wireline Services, you will ensure that Baker Hughes maximizes its short and long term revenue and profit opportunities by optimizing the utilization of its resources, As India Scheduling ...

Detailed Job Role: Monitor and document drug safety data, perform adverse event reporting, assist with pharmacovigilance and risk management. KRA (Key Responsibility Areas): Case assessment, adverse event documentation, timely reporting, risk communication KPI (Key Performance Indicators): Event processing time, report accuracy, submission regularity, follow-up efficiency Job description: Job Summary:We are seeking a meticulous Drug Safety Associate to monitor, document, and manage drug safety data while supporting pharmacovigilance and risk management activities. The ideal candidate will ensure timely and accurate reporting of adverse events, contributing to patient safety and regulatory co...

As a Process Equipment Systems Engineer in the pharmaceutical manufacturing industry, your primary responsibility will be to design and specify process equipment systems for manufacturing plants. This involves ensuring that the equipment aligns with project goals and meets regulatory standards such as GMP, FDA, and EMA. You will need to select appropriate equipment based on factors like material compatibility, process requirements, automation, and cost-effectiveness. Your role will also involve developing equipment specifications, datasheets, and technical documentation for procurement and installation purposes. It is essential to have hands-on experience in installing isolator-based filling...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.

To design, implement and maintain Quality Management Systems as per standards. Handle Internal Audits, Compliances, CAPA, Prepare reports on Quality Metrics etc.

About Shalina Healthcare: Shalina Healthcare is among the largest privately owned pharmaceutical businesses in Africa with its Global Headquarters based in Dubai, UAE. The company has recently diversified into new lines of businesses such as Digital Healthcare, Diagnostics, and Consumer Healthcare. Shalina Healthcare has a remarkable track record and its brands are highly trusted across Africa. With a vision to become the health champion of Sub-Saharan Africa by 2030, the company is seeking individuals who can contribute to its growth and make a positive impact on the communities it serves. If you share our Core Values and are passionate about our Mission, we welcome you to join us on this j...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in acco...

Role & responsibilities Program Planning and Strategy, Program Implementation and Coordination, Monitoring, Evaluation, and Reporting, Adoption of technology for various FDA functions, Compliance and Enforcement Support Initiatives for obtaining and Support maintaining laboratories assigned by or as the accreditation for FDA competent authority. Preferred candidate profile Master Degree in Food Technology/Food Science/ Dairy Technology or Biotechnology or Oil Technology or Agricultural Science or Veterinary Sciences or Blo-Chemistry or Microbiology or Chemistry or from a medicine recognized University having at least 3 years experience with regulatory bodies like FSSAI and State FDA knowledg...

Role & responsibilities Program Planning and Strategy, Program Implementation and Coordination, Monitoring, Evaluation, and Reporting, Adoption of technology for various FDA functions, Compliance and Enforcement Support Support Initiatives for obtaining and maintaining accreditation for FDA laboratories or as assigned by the competent authority Preferred candidate profile Master Degree in Pharmacy/Pharmaceuticals Science having at least 3-year experience with regulatory bodies like CDSCO, or State FDA units. He must have knowledge of Drugs and Cosmetics Act and other relevant Laws

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations including Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. Our manufacturing facility, situated in Vapi (Gujarat), holds approval from global regulatory authorities. Founded in 1983, UMEDICA operates in over 85 countries across the globe, encompassing EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. Upholding a culture of innovation & continuous improvement, we at UMEDICA constantly strive for excellence. We are currently looking for a dynamic and experienced Manager/ Sr. Manager specializing in ...

For the past 20 years, ProPharma has been dedicated to enhancing the health and well-being of patients through the provision of expert advice and guidance that enables biotech, medical device, and pharmaceutical organizations of all sizes to confidently progress scientific innovations and introduce new therapies. ProPharma collaborates with its clients utilizing an advise-build-operate model throughout the entire product lifecycle. With profound expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers a comprehensive suite of customizable consulting solutions that mitigate risks and exped...

To implement cGMP QC labo. pharma regulatory standards.• FDA of small molecule & analytical methods/equipment: GC, LC, ICP-MS, KF, LOD, ROI, optical rotation, RI, stability analysis, light obscuration, potentiometric titrations, spectroscopy

Job Title: QA/QC Senior Executive Department: Quality Reports To: Quality Head Key Responsibilities: Quality Control: Conduct regular inspections of raw materials, in-process products, and finished goods to ensure adherence to quality standards and specifications. Compliance: Ensure compliance with local and international food safety regulations and quality certifications (e.g., ISO, HACCP, FDA, FSSAI). Documentation & Reporting: Maintain accurate and up-to-date records for quality checks, production batches, testing results, and corrective actions. Prepare and present quality reports for internal teams and management. Process Improvement: Identify areas for process improvement and work clos...

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in No walk-in interviews on 27-Aug-25

SUMMARY Senior iOS Developer Build Mission-Critical Health-Tech Apps (On-site only) Company: Ajmera Infotech Private Limited (AIPL) Location: Ahmedabad, Bangalore/Bengaluru, Hyderabad (On-site) Experience: 4 8 years Position Type: Full-time, Permanent Shape Mobile Experiences That Save Lives AIPL’s 120-engineer team powers planet-scale systems for global innovators. We are assembling a specialised iOS squad to build FDA-compliant, SwiftUI -first apps for a billion-dollar health-tech platform (client name confidential). Your code will run on iPhones and iPads used daily by clinicians and patients worldwide software that simply cannot fail. What Makes This Role Exciting Greenfield + Legacy mod...

Assistant Project Manager At Morphedo Project Managers are mission navigators, balancing deep-tech uncertainty, multi-disciplinary teams, and long timelines. This is not Gantt charts for IT, its steering projects where stakes include lives and national security. You will oversee the end-to-end deep-tech product lifecycle, from ideation and R&D to prototyping, certification, and deployment ensuring technical excellence, regulatory compliance, and timely delivery. Problem Statements Youll Solve How do we deliver a rugged IoT device to the Indian Army that functions flawlessly at ?40C in Siachen How can we coordinate multi-disciplinary teams to build a new dialysis machine that meets CDSCO stan...

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. Youll find an environment that inspires and empowers you to thrive both personally and professionally. Theres no one like you and thats why theres nowhere like RSM. independent accounting, tax and consulting firms. RSMs vision is to be the first-choice advisor to middle market leaders globally. You will work directly with clients, key decision ma...