679 Fda Jobs - Page 23

Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.) Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you! Minimum Qualifications Knowledge of medical regulations ...

We are seeking a skilled and proactive Medical Device Cybersecurity Engineer to join our team. This position plays a critical role in ensuring the cybersecurity and regulatory compliance of our connected medical devices throughout the product lifecycle. The ideal candidate has hands-on experience in threat modeling, managing third-party software components, performing vulnerability scans and penetration testing, and collaborating across cross-functional teams to integrate robust cybersecurity controls in accordance with FDA and global regulatory requirements. Key Responsibilities: Perform and maintain comprehensive threat modeling (e.g., STRIDE) for embedded and connected medical devices. Pe...

Labware LIMS Functional consultant with experience in Labware LIMS, Labware ELN, Labware Mobile, LIMS V7, Implementation, rollouts, GXP, FDA, ISO,

Primary Function of Position: The Senior Quality Systems and Compliance Staff will provide leadership for ISI's quality systems function to ensure the overall quality management system (QMS) align with domestic and global regulatory requirements. Collaboration with business partners and management will be key to create and sustain a QMS infrastructure that is compliant, effective, efficient and agile to support a rapidly growing international business model with complex and diverse product lines. The Senior Quality Systems and Compliance Staff will have strong leadership skills to support established customer-focused quality initiatives plus maintain and improve the health of QMS. The leader...

Job Title: Manager - Sales & Marketing (API) Company: Calyx Chemicals & Pharmaceuticals Ltd Location: Vashi, Navi Mumbai Experience Required: 5 to 9 years Educational Qualification: Bachelor's degree in Pharmacy, Marketing, Business Administration or related field Job Purpose: Responsible for leading sales and marketing of Active Pharmaceutical Ingredients (APIs) by formulating strategies, driving business growth, developing key accounts, managing client relationships, and strengthening brand visibility across global markets. Key Responsibilities: Sales & Business Development: Develop and implement strategic sales plans to achieve revenue targets and market expansion. Identify and capture ne...

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

As a Research and Development (RD) Asst. Manger in Hair Care, you will play a pivotal role in the creation and testing of new hair care. You'll work closely with scientists, chemists, and other team members to ensure the smooth operation of lab processes and the development of innovative hair care range. This role requires a keen eye for detail, a passion for cosmetics, and the ability to adhere to strict quality and safety standards. Responsibilities: Lab Operations: Execute laboratory experiments and procedures. This includes preparing hair care product, conducting/monitor stability tests, and performing quality control checks. Formulation Development: Create formulation basis product brie...

Job purpose : The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities : Collaborates with other team members to define database requirements . Involves in ...

Role & responsibilities : Act as the lead internal auditor for medical device programs, ensuring compliance with ISO 13485 and U.S./EU regulations. Investigate non-conformances and implement effective corrective actions for medical device-related issues. Review onboarding checklists to ensure FDA and EU MDR requirements are met for all devices. Oversee compliance in shipping, labeling, and depot processes for investigational and commercial devices. Serve as the main contact during ISO 13485 audits and coordinate with logistics and external auditors. Monitor regulatory changes (FDA, EMA, MDR) and update quality systems accordingly. Administer the EDMS platform, managing system operations, use...

Role & responsibilities : Assist in the preparation, review, and submission of regulatory documents Help maintain regulatory files and records Support in compiling dossiers for product registrations and renewals Research regulatory requirements and updates from national/international authorities Coordinate with cross-functional teams for required data or documents Share your resume to hrd@stedmanpharma.com / 9786920463 Preferred candidate profile : This internship is ideal for students or recent graduates looking to gain hands-on experience in the field of Regulatory Affairs within the pharmaceutical industry. The intern will work closely with the RA team and assist with documentation, compl...

Department: Quality Assurance Reports To: Quality Control Manager Location: Thanjavur Job Summary: The Quality Control Specialist in a pharmaceutical company is responsible for ensuring that all products meet quality standards and regulatory requirements before they are released to the market. This role involves performing a variety of testing and analysis procedures on raw materials, in-process materials, and finished products. The Quality Control Specialist works closely with the production team to identify and resolve quality issues and contributes to the continuous improvement of quality systems and processes. Key Responsibilities: Conduct routine and non-routine testing of raw materials...

Interested candidates share resume to sanjay.behera@thyrocare.com or whatsapp to 8928285213 Company Description : Nueclear Healthcare Limited is a nationwide network of medical cyclotrons and PET-CT centers, focused on delivering affordable, high-quality nuclear medicine diagnostic solutions for cancer patients. Our business model reflects a strong commitment to both social responsibility and service excellence, ensuring that every patient receives safe, accurate, and timely care. Role: Radiochemist (Full-Time, On-Site Mumbai) We are seeking a dedicated and skilled Radiochemist to join our team in Mumbai. This is a full-time, on-site position that involves overseeing daily radiopharmaceutica...

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI. Inviting applications for the role of Regulatory Engineer! In this role - The team developing industry leading X-ray generation subsystems is looking f...

Key Responsibilities: Project Delivery & Oversight Lead end-to-end delivery of MedTech projects, including software platforms, connected devices, and digital health tools. Define project scope, goals, and deliverables in collaboration with stakeholders. Manage timelines, budgets, and resource allocation. Stakeholder Management Act as the primary liaison between clinical teams, IT, vendors, and regulatory bodies. Translate clinical and business requirements into technical specifications. Compliance & Quality Ensure all solutions comply with healthcare regulations (e.g., FDA, MDR, HIPAA). Oversee validation, testing, and documentation processes. Team Leadership Lead cross-functional teams incl...

JD @ QC Executive will ensure that products meet quality standards & regulatory requirements with analyzing samples, conducting tests, maintaining documentation & more Accommodation, Meals & Transport from client side Saturdays are Half day

Testing of food samples(frozen/solid/liquid/breverages) as per IS/ISO/FDA/EPA methods Maintenance of NABL documents Media and sample preparation, media performance and method validation test.

Company Name: A wholly owned subsidiary of Alkem MedTech Private Limited. Purpose of the role: The Engineering and Facilities Lead is responsible for overseeing and managing all engineering and facilities operations within the organization. This includes ensuring the safe, efficient, and compliant operation of the companys facilities, including shopfloor, laboratories, and office spaces. The role involves leading a team to maintain and improve facilities systems, equipment, and infrastructure, ensuring that all operations meet regulatory standards, safety requirements, and operational efficiency targets. Roles & Responsibilities: Facilities Management & Operations: Oversee the day-to-day ope...

Role & responsibilities Liaison with Food & Drugs Control Administration, Gandhinagar/circle offices/CDSCO for various applications including but not limited to Product Permissions for manufacturing COPPs Various certificates for tender (FSC, Performance certificate, Non-conviction certificate) Inspections for WHO GMP/Schedule M GMP certification Technical persons approval Technical person application verification. Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale licences Submission of commercial batches to CDL Kasauli for testing Submission of quarterly returns to NCB/CBN Handling NSQs Experience in submissions throug...

Role & responsibilities To establish the quality, health & safety policies, procedures, standards and specifications Maintain Certificate of Conformity for all our Products To work with the procurement team & production team to ensure quality standards To look at ways to reduce waste and increase efficiency; To set audit/ inspection procedures, protocol and checklist To conduct periodical inspections at the supplier location & also our warehouse for quality control, evaluate problems and suggest corrective action Focus on Continuous Improvement Preferred candidate profile Women candidate with Graduate in BSC Chemistry / B Pharma

Regulatory Submissions Publisher – Mumbai/Bengaluru (Night Shift). Prepares & QC’s regulatory dossiers (IND, NDA, CTA, BLA, IMPD, MAA) for US, EU, Canada, ANZ. Handles EDMF, COS/CEP, MRP/DCP/CP filings Required Candidate profile Requires 2+ yrs pharma publishing exp, Documentum/Liquent Insight skills, MS Office proficiency. Must have international BPO exp, grad degree, and be based in Mumbai/Bangalore. No ex-TCS candidates.

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formu...

Responsibilities: Review of formulation development documents like trade dress for new product, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report. Health insurance Provident fund

Role & responsibilities Responsibilities: - Oversee and manage quality control processes and procedures within the organization - Develop and implement quality control standards and guidelines - Conduct regular inspections and audits to ensure compliance with quality standards - Analyze data and trends to identify areas for improvement and implement corrective actions - Collaborate with cross-functional teams to address quality issues and drive continuous improvement - Train and mentor QC staff to ensure adherence to quality control protocols - Prepare and maintain documentation related to quality control activities - Participate in regulatory inspections and audits as needed

* Urgent job opening for Production Chemist for reputed Chemical Manufacturing Company with B.Sc. / M.Sc. ( Chemistry) near Vadodara Location. * Experience in FDA Approved in Bulk Drugs Manufacturing

: Job Title Regulatory Advisory Analyst Location Bangalore, India Corporate TitleAssociate Role Description The Regulatory & Exam Management ("R&EM) team is responsible for not only coordinating the Bank's relationships with its regulators but also overseeing any external party engagement or exam administration related to regulatory assigned monitors, consultants and/or auditors for all CAO related matters, from inception through field work and ultimately report generation, distribution and findings upload in GFMS. The team's success is rooted in following these four main principles: Drive consistent communication to our regulators; Organize staff based on residing location and functional ar...