13 Us Fda Jobs

The Engineering Manager will lead the engineering and maintenance functions for the Oncology Manufacturing Facility, ensuring reliability, compliance, and operational excellence. The role requires deep expertise in sterile and injectable pharmaceutical environments, with a strong focus on equipment performance, utilities management, and team leadership. Key Responsibilities: 1. Maintenance and Reliability Management Oversee maintenance operations to ensure optimal performance of production equipment, including lyophilizers, injectable filling lines, and rapid mixer grinders. Develop and execute preventive maintenance programs to minimize downtime and ensure uninterrupted manufacturing. Monit...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Role Summary The QARA Director for India will be responsible for leading a team supporting Quality Assurance and Regulatory Affairs activities in India. This leadership role is responsible for developing and executing regulatory strategies and maintaining quality related activities and systems to ensure compliance with Indian and international medical device regulations (e.g. CDSCO, ISO 13485/Indian GMP, US FDA, EU MDR). The QA/RA Dire...

As an Assistant Manager in Regulatory Affairs at our Haridwar factory, your primary role will be to review product formulations in accordance with Indian FDA (Cosmetics & Ayurvedic) regulation, EU Cosmetics Regulation (EC 1223/2009), US FDA, ASEAN, and GCC guidelines. Your responsibilities will include preparing and maintaining regulatory dossiers such as Product Information Files (PIF) and safety assessments to meet export requirements. You will also be tasked with reviewing product labels, ingredient lists, and claims to ensure compliance with country-specific regulations. Additionally, you will be responsible for preparing Product Safety Data Sheets as per export regulations and staying u...

Salary Between 15-20 Lacs QA-Validation Sterile Injectables (Candidate with B1/B2 USA Visa Preferred) Experience Required: 10-15 years Location: Remote Department: Quality Assurance No. of vacancy: 01 Key Responsibility: Validation Activities: Prepare, review, and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity. Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions. Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade AD) based on environmental monitoring and qualification data from the site. Prepare and review periodic requalification protoc...

You should have a Masters or Bachelors degree in Science / Pharmacy along with at least 7-10 years of experience in a similar function within the pharmaceutical industry. As a Regulatory Affairs professional, you must have supported regulatory affairs functions on finished dosage forms. It is essential to possess a sound and deep knowledge of current Regulatory / GMP requirements including US FDA, EU GMP, and PIC/s. Your role will require strong initiative skills, enabling you to work both independently and as part of a team. Proficiency in English communication is vital for effective coordination within the organization and with external stakeholders. Additionally, you should have advanced ...

JOB DESCRIPTION: Job Title: Regulatory Affairs Specialist - Medical Devices Location: New Delhi Department: Regulatory Affairs Reports To: Regulatory Affairs Manager Job Summary: The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance. Key Responsibilities: Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authori...

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, support...

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities incl...

You should have a minimum of 5 years of experience in the packing department within the pharmaceutical, healthcare, or food processing industry. Your experience should include familiarity with Lean, OEE, and similar KPIs, as well as hands-on experience with UK MHRA or US FDA procedures. Additionally, you should have experience in equipment procurement, installation, startup, validation, and trial production run of a new WHO GMP compliant packing facility. As a part of your duties and responsibilities, you will be required to manage the packaging processes, ensure and control packaging activities, monitor yield losses during the packaging process, and ensure cost-effective packing material co...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...

Job Title: QARA ENGINEER Experience: 4.5 to 10 years Location: Bangalore Mandatory Skill: US FDA, 510K, PMA, EU MDR, QARA. Regulatory gap assessment and remediation. Job Description: The objective of this project is to identify and remediate any deficiencies in the design history files (DHF) and device master records (DMR) of the stent graft integrated with 4 branched vascular prosthesis - FROZENIX 4 Branched, ensuring adherence to relevant standards, US Food and Drug Administration ("FDA") guidelines and regulations requirements by completing all necessary tasks including document translation (Japanese to English), gap assessment, remediation and submission query support. Design verificatio...

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Studying Legal Documents and collating info in a variety of formats. Ensuring compliance with regulations set by the Cosmetics & Perfumes Regulatory Agency as country wise Keeping up to date with changes in regulatory legislation and guidelines Required Candidate profile Well versed with US FDA, EU regulatory requirements Be well versed in the preparation of MSDS, COA, PIF and CPNP files Knowledge on Indian Drug & Cosmetic mfg Act especially on Schedule S Stds & GMP.