679 Fda Jobs - Page 15

Position Summary: Freyr is seeking an experienced individual to join their Medical Device Team. This position involves working directly with clients with software enabled medical devices or software as a medical device to serve as an advisor on regulatory strategy including the development of regulatory strategy documents, documentation to support premarket submissions, and preparation and submission of premarket applications as well as participation in FDA meetings and other regulatory interactions. The role is 50% billable with the remaining time being devoted to business development/marketing as well as mentorship and training of the more junior staff. The ideal candidate will possess in-...

You will be responsible for preparing and adhering to the annual planner for Quality audits for Loan Licence Units (LLU), Third-Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs) to ensure GMP and GLP compliance. This includes conducting periodic, due diligence, and for-cause quality audits to monitor overall performance. You will review audit compliance reports for any external, regulatory, or customer audits, ensuring the closure of individual observations by reviewing relevant supporting data. Additionally, you will conduct self-inspections of individual departments, compile reports, track and review compliance for timely closure, and maintain audit ...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

Develop business for Excipients & Fine chemicals with pharmaceutical Liaise with Pharma companies Prepare techno-commercial proposals Address customer queries Monitor market trends Maintain and update customer databases Ensure all documentation Required Candidate profile knowledge of pharma excipients & APIs Strong documentation handling skills (compliance, quality certifications, VQ’s) Customer relationship management Strong communication Proficiency in MS Office

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You should be able to recognize patient needs and prioritize those needs with the requirements outlined by physicians. Responsibilities - Assure quality care by adhering to standards set by the physicians. - Provide care education to patients in person or over the phone. - Adhere to compliance guidelines throughout processes (OSHA, FDA, HIPAA). Qualifications - Must be a Registered Professional Nurse with current licensure. - CPR, ACLS, and BCLS Certification. - Knowledge of OSHA, FDA, and HIPAA compliance. - You must be able to lift and position patients on an endoscopy stretcher a...

The ideal candidate will be responsible for providing care to patients while adhering to compliance standards. You will be expected to recognize patient needs and prioritize them in alignment with the directives provided by physicians. Your role will involve assuring quality care according to the standards set by physicians, providing education on care to patients either in person or via telephone, and ensuring compliance with guidelines such as OSHA, FDA, and HIPAA throughout the processes. To qualify for this position, you must hold a current licensure as a Registered Professional Nurse. Additionally, you should possess certifications in CPR, ACLS, and BCLS. Knowledge of OSHA, FDA, and HIP...

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 ...